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| Name | Class |
|---|---|
| Disarm Therapeutics | INDUSTRY |
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This pilot study will attempt to establish the feasibility of using tissue oxygen measurements and the protein, neurofilament light chain (NF-L), as potential biomarkers for chemotherapy-induced peripheral neuropathy (CIPN). Thirty (30) subjects scheduled to begin taxane-based chemotherapy for breast tumor will be assigned to receive an India ink injection under the skin of the foot. The ink will be used to make up to five (5) 45-minute "electron paramagnetic resonance" (EPR) oximetry readings prior to the start of chemotherapy. Subjects will undergo electrophysiologic assessments including nerve conduction studies, in addition to a neurological examination prior to the start of chemotherapy. Subjects will have the EPR oximetry readings, electrophysiologic tests, and neurological examination two more times: at the halfway point of their chemotherapy treatment -- or at the onset of CIPN symptoms -- and again after chemotherapy has been completed. Subjects will also have blood drawn prior to beginning taxane-based chemotherapy, prior to every scheduled chemotherapy treatment, and after completion of chemotherapy in order to test for neurofilament light chain (NF-L).
Therapy with chemotherapeutic drugs can make a huge impact on survival and quality of life in patients with cancer. Advances in medical monitoring and the effectiveness of these therapies have significantly improved outcomes so that a definitive cure or long-term survival is more likely. Cancer survivors are used to dealing with serious side effects of their therapy; however, some of the side effects from the chemotherapy drugs persist even after the medication course is completed. The impact of these sequelae on quality of survival is increasingly being appreciated and forming an important new direction of cancer care. One of the more severe side effects of chemotherapy is peripheral neurotoxicity resulting in neuropathy or neuronopathy.
Chemotherapy-induced peripheral neurotoxicity (CIPN) is one of the least predictable and most prolonged sequelae with effects ranging from pain, numbness and tingling to diffuse weakness sometimes to the extent of paralysis. It results from damage or alteration in function of peripheral nerves usually, but not always, in a length-dependent manner. An indirect impact of CIPN includes difficulties with balance and susceptibility to falls. There are currently no therapies that have been proven to prevent CIPN. Similarly, there are few medications that are known to be effective in the reversing CIPN once it develops or effectively treating symptoms of CIPN. Currently, diagnosis is based mainly on clinical examination and electrophysiological testing to monitor CIPN; identification of candidate biomarkers through which disease onset can be identified at an earlier stage and which reflect presumed pathophysiologic mechanisms is of paramount importance.
There are different theories of CIPN pathogenesis. One of the leading hypotheses relates to mitochondrial dysfunction and oxidative stress affecting both the dorsal root ganglia neurons and supportive endothelial cells of the vasa nervorum. Here at Dartmouth, a specialized technique has been developed that allows the non-invasive assessment of tissue oxygen in and around peripheral nerve. This technique, called "electron paramagnetic resonance" (EPR) oximetry, allows for repeated measurements over time that can be correlated with other metrics of peripheral nerve function. Given its relevance to an important pathophysiologic mechanism of disease, EPR oximetry may provide an early marker of disease onset.
Neurofilament light chain (NF-L) is also emerging as a sensitive blood-based biomarker of axonal degeneration. NF-L is a component of the axonal cytoskeleton that leaks out of degenerating axons. NF-L has been reported to be elevated in plasma or serum in a wide range of neurodegenerative disorders, including CNS disorders such as multiple sclerosis and ALS as well as PNS disorders such as Charcot Marie Tooth and Guillain-Barre syndrome. To date, there are no published reports of elevated blood NF-L levels in patients with CIPN, although it has been reported to increase in rat model of vincristine-induced neuropathy.
In this proposal, the investigators will be testing the hypothesis that these could both be biomarkers of CIPN. It is hoped that the oximetry measurement and blood NF-L levels will (i) reflect the changes that occur on a cellular level and the damaged nerves, (ii) reflect the damage occurring to nerves more sensitively than existing techniques, and (iii) help to better understand the reason the nerves are being damaged. It is also hoped that these will be something that can be used in future clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EPR Oximetry | Experimental | All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points (pre-exposure, during-exposure or CIPN incidence, and post exposure), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EPR Oximetry | Diagnostic Test | Subjects will have up to five EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change in % pO2 | EPR Oximetry will measure tissue oxygen levels in the injected foot during 10 minutes of breathing room air, 10 minutes while breathing 100% oxygen, and 10 minutes of room air. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Neurologic Examination_ Strength_ Toe Fan | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Victoria H Lawson, M.D. | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center in Lebanon, NH | Lebanon | New Hampshire | 03766 | United States |
Individual participant data is not intended to be shared with other researchers per the current protocol and informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | EPR Oximetry | All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points (pre-exposure, during-exposure or CIPN incidence, and post exposure), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing. EPR Oximetry: Subjects will have up to five EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EPR Oximetry | All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points (pre-exposure, during-exposure or CIPN incidence, and post exposure), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing. EPR Oximetry: Subjects will have up to five EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relative Change in % pO2 | EPR Oximetry will measure tissue oxygen levels in the injected foot during 10 minutes of breathing room air, 10 minutes while breathing 100% oxygen, and 10 minutes of room air. | 3 patients underwent testing. 1 patient did not undergo the 100% oxygen condition at the End of Chemo, so there is no data for Mid-Point or recovery for that patient. Data was not gathered for the remaining 4 participants. | Posted | Mean | Full Range | change in % oxygenation | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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Adverse events will be reported from the initiation of any study procedures to the end of the study treatment follow-up. Adverse events were collected from Baseline through 15 - 18 weeks after chemotherapy.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EPR Oximetry | All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points (pre-exposure, during-exposure or CIPN incidence, and post exposure), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing. EPR Oximetry: Subjects will have up to five EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Vascular disorders | Systematic Assessment | Erythema on chest wall over mastectomy site |
LIMITATION OF EPR DATA While it may be feasible to make serial measurements with the technique, there were technical problems with the sensor (India Ink), and no conclusions can be drawn in regard to oxygenation. Additionally, the ERP data are limited.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Victoria Lawson | Dartmouth Hitchcock Medical Center | (603) 650-5104 | victoria.h.lawson@hitchcock.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2018 | Jul 7, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 28, 2021 | Jul 12, 2023 | ICF_001.pdf |
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| Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Neurologic Examination_ Strength_ Toe Flex | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Neurologic Examination_ Strength_ Inv | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Neurologic Examination_ Strength_ Ev | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Neurologic Examination_ Strength_ ADF | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Neurologic Examination_ Vibration Sense_Toe | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Neurologic Examination_ Vibration Sense_MM | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Neurologic Examination_ Vibration Sense_Knee | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Neurologic Examination_ Vibration Sense_DIP2 | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Neurologic Examination_ Vibration Sense_DIP5 | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Neurologic Examination_ Deep Tendon Reflexes _ Biceps | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Neurologic Examination_ Deep Tendon Reflexes _ Triceps | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Neurologic Examination_ Deep Tendon Reflexes _ BR | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Neurologic Examination_ Deep Tendon Reflexes _ Patella | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Neurologic Examination_ Deep Tendon Reflexes _ Achilles | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Mean Nerve Conduction Metrics (Amplitude)_DORSAL SURAL | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Change in Nerve Conduction Metrics (Amplitude)_MED PLANTAR | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Change in Nerve Conduction Metrics (Amplitude)_SURAL | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Mean of the Difference in Nerve Conduction Amplitudes Between Pre-Mid and Pre-Post exposure_Dorsal Sural | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. The outcome measure is reporting the average of the differences in amplitudes Pre-Mid and Pre-Post exposure (for example, the change from Pre and Mid is calculated, and then the change across all participants is averaged). | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Change in Nerve Conduction/Mixed Nerve Amplitudes _Medial Plantar | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Change in Nerve Conduction/Mixed Nerve Amplitudes _Sural | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Change in Nerve Conduction_Motor_ (Amplitude)_Peron-EDB | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Change in Nerve Conduction_Motor_ (Amplitude)_Peron-TA | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Change in Nerve Conduction_Motor_ (Amplitude)_Tibial-AH | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP AMP, EDB | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP, AT | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Tibial CMAP, AH | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Dorsal Sural CV | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Med Plantar CV | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Sural CV | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CV, Distal | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Mean Score of Neuro-Quality of Life - Positive Affect and Well-Being Scale | Neuropathy-Specific Quality of Life scale measuring Positive Affect and Well Being The range in score is 23 to 115, with a low score indicating a less positive affect and well-being | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Mean Score of Neuro-Quality of Life - Satisfaction With Social Roles and Activities Scale | Neuropathy-Specific Quality of Life scale measuring Satisfaction with Social Roles and Activities The range in scores is 47 to 235, with a lower score indicating less satisfaction with social roles and activities | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Mean Score of Neuro-Quality of Life - Lower Extremity Function (Mobility) Scale | Neuropathy-Specific Quality of Life scale measuring Lower Extremity Function (Mobility) The range in scores is 19 to 95, with a lower score indicating more difficulty with lower extremity function | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Mean Score of Neuro-Quality of Life - Upper Extremity Function (Fine Motor, Activities of Daily Living) Scale | Neuropathy-Specific Quality of Life scale measuring Upper Extremity Function (Fine Motor, Activities of Daily Living) The range in scores is 20 to 100, with a low score indicating more difficulty with upper extremity function | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Mean Score of The Neuropathy Total Symptom Score-6 Questionnaire | Neuropathy Total Symptom Score questionnaire with 6 questions The range is scores is 0 to 22 with a higher score indicating worse symptoms | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Mean Score of Toronto Clinical Neuropathy Scoring System | Toronto Clinical Neuropathy Scoring System The range in scores is 0 to 19 with higher scores indicating worse neuropathy | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Mean Score of National Cancer Institute - Common Toxicity Criteria | National Cancer Insitute - Common Toxicity Criteria The range in scores is 0 to 5, with higher scores indicating worse toxicity | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Mean Score of Total Neuropathy Scores | Total Neuropathy score The range in scores is 0 to 40, with higher scores indicating worse neuropathy | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Mean Score of Survey of Autonomic Symptoms, Column B | Survey of Autonomic Symptoms, questions in Column B The range in scores is 0 to 55 for women and 0 to 60 for men, with higher scores indicating more bothersome symptoms | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Mean Score of McGill Pain Visual Analog Scale | McGill Visual Analog Scale for Pain The range in scores is 0 to 100, with 0 indicting "No pain" and 100 indicating "Worst pain possible" | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Mean Scores of Short Form McGill Pain Questionnaire | Short Form McGill Pain Questionnaire The range in scores is 0 to 15, with higher scores indicating worse pain | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Mean Score of Survey of Autonomic Symptoms, Column A | Survey of Autonomic Symptoms, questions in column A The range in scores is 0 to 11 for women and 0 to 12 for men, with higher scores indicating more symptoms | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
| Serum NF-L Levels | Changes in serum NFL levels over the course of chemotherapy will be monitored to determine if NFL can be used as a biomarker for axonal damage in patients who develop CIPN. NFL will be measured at baseline, before each round of chemotherapy and at the completion of chemotherapy. Changes in NFL will be compared between patients who develop CIPN and those that do not. | 1 year |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
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| OG001 | Relative % pO2 Change From Baseline While Breathing 100% Oxygen | All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing. EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again. |
| OG002 | Relative % pO2 Change From Baseline While Breathing Room Air (Recovery) | All subjects in the study will receive the paramagnetic India ink injection to the foot. At three time points: pre-exposure (Baseline), during-exposure or CIPN incidence (Mid-Point), and post exposure (End of chemo), subjects will have three EPR oximetry readings, a neurological examination, and electrophysiologic testing. EPR Oximetry: Subjects will have EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again. |
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| Secondary | Neurologic Examination_ Strength_ Toe Fan | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction | Posted | Mean | Standard Deviation | Units on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Neurologic Examination_ Strength_ Toe Flex | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction | Posted | Mean | Standard Deviation | Units on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Neurologic Examination_ Strength_ Inv | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction | Posted | Mean | Standard Deviation | Units on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Neurologic Examination_ Strength_ Ev | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction | Posted | Mean | Standard Deviation | Units on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Neurologic Examination_ Strength_ ADF | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. MRC scale for muscle strength (0-5) Grade 5: Normal Grade 4: Movement against gravity and resistance Grade 3: Movement against gravity over (almost) the full range Grade 2: Movement of the limb but not against gravity Grade 1: Visible contraction without movement of the limb (not existent for hip flexion) Grade 0: No visible contraction | Posted | Mean | Standard Deviation | Units on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Neurologic Examination_ Vibration Sense_Toe | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense. | Posted | Mean | Standard Deviation | Units on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Neurologic Examination_ Vibration Sense_MM | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense. | Posted | Mean | Standard Deviation | Units on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Neurologic Examination_ Vibration Sense_Knee | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense. | Posted | Mean | Standard Deviation | Units on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Neurologic Examination_ Vibration Sense_DIP2 | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense. | Posted | Mean | Standard Deviation | Units on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Neurologic Examination_ Vibration Sense_DIP5 | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. The position of the intersect is recorded on an arbitrary scale from 0 to 8 on a Rydel-Seiffer tuning fork once the subject is no longer perceiving vibration. The higher the number, the better the vibratory sense. | Posted | Mean | Standard Deviation | Units on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Neurologic Examination_ Deep Tendon Reflexes _ Biceps | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal. | Posted | Mean | Standard Deviation | Units on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Neurologic Examination_ Deep Tendon Reflexes _ Triceps | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal. | Posted | Mean | Standard Deviation | Units on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Neurologic Examination_ Deep Tendon Reflexes _ BR | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal. | Posted | Mean | Standard Deviation | Units on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Neurologic Examination_ Deep Tendon Reflexes _ Patella | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal. | Posted | Mean | Standard Deviation | units on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Neurologic Examination_ Deep Tendon Reflexes _ Achilles | Patients will be phenotyped by a neurologic examination before and after exposure to a standard regimen of neurotoxic chemotherapy. REFLEX SCALE for Deep Tendon Reflexes (DTRs) The score ranges from 0 - 9, where 0 is no reflex response (areflexia)/always abnormal, greater than 1 and less than 3 is normal, and 9 is a tap that elicits a repeating reflex (clonus)/always abnormal. | Posted | Mean | Standard Deviation | units on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Mean Nerve Conduction Metrics (Amplitude)_DORSAL SURAL | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | uV | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Change in Nerve Conduction Metrics (Amplitude)_MED PLANTAR | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | uV | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Change in Nerve Conduction Metrics (Amplitude)_SURAL | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | uV | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Mean of the Difference in Nerve Conduction Amplitudes Between Pre-Mid and Pre-Post exposure_Dorsal Sural | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. The outcome measure is reporting the average of the differences in amplitudes Pre-Mid and Pre-Post exposure (for example, the change from Pre and Mid is calculated, and then the change across all participants is averaged). | Pre-Mid- is prior to chemotherapy exposure Pre-Post- is one week or more after chemotherapy completion | Posted | Mean | Full Range | uV | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Change in Nerve Conduction/Mixed Nerve Amplitudes _Medial Plantar | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-Mid- is prior to chemotherapy exposure Pre-Post- is one week or more after chemotherapy completion | Posted | Mean | Full Range | uV | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Change in Nerve Conduction/Mixed Nerve Amplitudes _Sural | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre-Mid- is prior to chemotherapy exposure Pre-Post- is one week or more after chemotherapy completion | Posted | Mean | Full Range | uV | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Change in Nerve Conduction_Motor_ (Amplitude)_Peron-EDB | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | mV | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Change in Nerve Conduction_Motor_ (Amplitude)_Peron-TA | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | mV | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Change in Nerve Conduction_Motor_ (Amplitude)_Tibial-AH | Electrophysiologic testing will measure nerve conduction amplitude in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | mV | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP AMP, EDB | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | For the dorsal sural sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy | Posted | Mean | Full Range | m/s | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CMAP, AT | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | For the dorsal sural sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy | Posted | Mean | Full Range | m/s | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Tibial CMAP, AH | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | For the dorsal sural sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy | Posted | Mean | Full Range | m/s | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Dorsal Sural CV | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | For the dorsal sural sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy | Posted | Mean | Full Range | m/s | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Med Plantar CV | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | For the Med Plantar sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy | Posted | Mean | Full Range | m/s | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Sural CV | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | For the Sural sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy | Posted | Mean | Full Range | m/s | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Nerve Conduction Metrics as Measured by Mean Change (Velocity) for Peroneal CV, Distal | Electrophysiologic testing will measure nerve conduction velocity in patients before and after exposure to a standard regimen of neurotoxic chemotherapy. | For the Peroneal CV, distal sensory nerve, a change in mean velocity pre-chemotherapy to mid-chemotherapy is reported as well as the change in mean velocity for pre-chemotherapy to post-chemotherapy | Posted | Mean | Full Range | m/s | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Mean Score of Neuro-Quality of Life - Positive Affect and Well-Being Scale | Neuropathy-Specific Quality of Life scale measuring Positive Affect and Well Being The range in score is 23 to 115, with a low score indicating a less positive affect and well-being | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion. | Posted | Mean | Standard Deviation | score on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Mean Score of Neuro-Quality of Life - Satisfaction With Social Roles and Activities Scale | Neuropathy-Specific Quality of Life scale measuring Satisfaction with Social Roles and Activities The range in scores is 47 to 235, with a lower score indicating less satisfaction with social roles and activities | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | score on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Mean Score of Neuro-Quality of Life - Lower Extremity Function (Mobility) Scale | Neuropathy-Specific Quality of Life scale measuring Lower Extremity Function (Mobility) The range in scores is 19 to 95, with a lower score indicating more difficulty with lower extremity function | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | score on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Mean Score of Neuro-Quality of Life - Upper Extremity Function (Fine Motor, Activities of Daily Living) Scale | Neuropathy-Specific Quality of Life scale measuring Upper Extremity Function (Fine Motor, Activities of Daily Living) The range in scores is 20 to 100, with a low score indicating more difficulty with upper extremity function | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | score on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Mean Score of The Neuropathy Total Symptom Score-6 Questionnaire | Neuropathy Total Symptom Score questionnaire with 6 questions The range is scores is 0 to 22 with a higher score indicating worse symptoms | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | score on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Mean Score of Toronto Clinical Neuropathy Scoring System | Toronto Clinical Neuropathy Scoring System The range in scores is 0 to 19 with higher scores indicating worse neuropathy | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | score on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Mean Score of National Cancer Institute - Common Toxicity Criteria | National Cancer Insitute - Common Toxicity Criteria The range in scores is 0 to 5, with higher scores indicating worse toxicity | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | score on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Mean Score of Total Neuropathy Scores | Total Neuropathy score The range in scores is 0 to 40, with higher scores indicating worse neuropathy | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | score on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Mean Score of Survey of Autonomic Symptoms, Column B | Survey of Autonomic Symptoms, questions in Column B The range in scores is 0 to 55 for women and 0 to 60 for men, with higher scores indicating more bothersome symptoms | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | score on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Mean Score of McGill Pain Visual Analog Scale | McGill Visual Analog Scale for Pain The range in scores is 0 to 100, with 0 indicting "No pain" and 100 indicating "Worst pain possible" | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | score on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Mean Scores of Short Form McGill Pain Questionnaire | Short Form McGill Pain Questionnaire The range in scores is 0 to 15, with higher scores indicating worse pain | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | score on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Mean Score of Survey of Autonomic Symptoms, Column A | Survey of Autonomic Symptoms, questions in column A The range in scores is 0 to 11 for women and 0 to 12 for men, with higher scores indicating more symptoms | Pre- is prior to chemotherapy exposure Mid- is midway through chemotherapy regimen Post- is one week or more after chemotherapy completion | Posted | Mean | Standard Deviation | score on a scale | Pre-chemotherapy (Baseline), Mid-chemotherapy (approximately 6 - 8 weeks from Baseline), Post-chemotherapy (approximately 2 - 3 weeks after the participant completed chemotherapy or approximately 14 - 18 weeks from Baseline) |
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| Secondary | Serum NF-L Levels | Changes in serum NFL levels over the course of chemotherapy will be monitored to determine if NFL can be used as a biomarker for axonal damage in patients who develop CIPN. NFL will be measured at baseline, before each round of chemotherapy and at the completion of chemotherapy. Changes in NFL will be compared between patients who develop CIPN and those that do not. | Samples were never gathered due to no participants enrolled after protocol was amended to include the collection of serum NF-L. | Posted | 1 year |
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| 0 |
| 7 |
| 0 |
| 7 |
| 6 |
| 7 |
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| Nausea | General disorders | Systematic Assessment | Nausea |
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| Increased symptoms of reflux | General disorders | Systematic Assessment | increased symptoms of reflux |
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| Abnormal Lab Values | General disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| High LFT's | General disorders | Systematic Assessment |
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| Increased Fatigue | General disorders | Systematic Assessment |
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| Soreness in both walls along MRM incision | General disorders | Systematic Assessment |
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| CIPN | Nervous system disorders | Systematic Assessment | length-dependent, axonal sensory motor neuropathy |
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| Redness/Itchy on scalp | General disorders | Systematic Assessment | Little red bumps on scalp that are itchy |
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| Cramping in calves- severe | General disorders | Systematic Assessment |
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| Discomfort in anterior aspect of shins | General disorders | Systematic Assessment |
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| Decreased Dexterity | General disorders | Systematic Assessment |
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| Increased unsteadiness | General disorders | Systematic Assessment |
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| Chest Pain | General disorders | Systematic Assessment |
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| Indigestion | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Sore Throat due to Nocturnal Epistaxis | General disorders | Systematic Assessment |
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| Alopecia | General disorders | Systematic Assessment |
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| Anemia-Mild | General disorders | Systematic Assessment |
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| Dysphagia | General disorders | Systematic Assessment |
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| High WBC w/o infection | General disorders | Systematic Assessment |
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| Thrush on tongue | General disorders | Systematic Assessment |
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| Low K+ Lab | General disorders | Systematic Assessment |
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| Diverticulitis | General disorders | Systematic Assessment |
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| Shortness of breath | General disorders | Systematic Assessment |
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| left ankle swelling-occasional | General disorders | Systematic Assessment |
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| Pain during urination | General disorders | Systematic Assessment |
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| Worsening Appetite | General disorders | Systematic Assessment |
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| Knee Pain | General disorders | Systematic Assessment |
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| Pain up to hip from knee | General disorders | Systematic Assessment |
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| Shingles | General disorders | Systematic Assessment |
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| Cellulitis | General disorders | Systematic Assessment |
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| Bloating | General disorders | Systematic Assessment |
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| Dry Mouth | General disorders | Systematic Assessment |
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| Hyperhidrosis | General disorders | Systematic Assessment |
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| Brief periods of heart pounding | General disorders | Systematic Assessment |
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| Aches, Cramps and Spasms | General disorders | Systematic Assessment |
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| Sore on tip of tongue | General disorders | Systematic Assessment |
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| Brief burning sensation on chest, back, and legs | General disorders | Systematic Assessment |
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| Low grade fever | General disorders | Systematic Assessment |
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| Ecchymosis | General disorders | Systematic Assessment |
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| Bilateral ankle swelling | General disorders | Systematic Assessment |
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| Myalgia | General disorders | Systematic Assessment |
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| Cytopenia | General disorders | Systematic Assessment |
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| Discomfort at Injection Site | General disorders | Systematic Assessment |
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| Right Hip/Lower back pain | General disorders | Systematic Assessment |
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| Myalgias | General disorders | Systematic Assessment |
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| Fever | General disorders | Systematic Assessment |
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| Mild Cough | General disorders | Systematic Assessment |
|
| Mild Anemia | General disorders | Systematic Assessment |
|
| Arthralgias | General disorders | Systematic Assessment |
|
| Dysgeusia | General disorders | Systematic Assessment |
|
| Acute Pharyngitis | General disorders | Systematic Assessment |
|
| Pain at injection site | General disorders | Systematic Assessment |
|
| Purple Hematoma at injection site | General disorders | Systematic Assessment |
|
| Rash-under Arm Pit | General disorders | Systematic Assessment |
|
| Redness along hands and wrists | General disorders | Systematic Assessment |
|
| Mouth Sore | General disorders | Systematic Assessment |
|
| Tearing of eyes | General disorders | Systematic Assessment |
|
| Allergic Reaction | General disorders | Systematic Assessment |
|
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