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The primary objective of this study is to select the best intervention from cold therapy, compression therapy and placebo at reducing neuropathic pain as measured by the change in the Neurotoxicity (NTX) component of the Functional Assessment of Cancer Therapy (FACT) - Taxane questionnaire, following 12 weeks of neoadjuvant/adjuvant chemotherapy with paclitaxel or docetaxel among breast cancer patients.
Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent side effect resulting from the administration of cytotoxic chemotherapeutic agents. The incidence of CIPN can vary on the type of agent used, the frequency with which it is given, and the cumulative dose. Unfortunately, for some patients, symptoms may persist even after discontinuation of the drug due to irreversible nerve damage. As of now, there are no established agents for CIPN prevention.
This is a randomized, placebo-controlled clinical selection trial of interventions for CIPN in patients treated with docetaxel every 3 weeks or paclitaxel on a weekly schedule. Patients will be randomly assigned to receive either frozen gloves and socks, compression gloves and socks, or "loose" gloves and socks (placebo arm) during chemotherapy infusion to study the best intervention at reducing neuropathic pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryotherapy | Active Comparator | Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks. |
|
| Compression Therapy | Active Comparator | Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks. |
|
| Control arm (Loose glove/sock) | Placebo Comparator | Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryotherapy | Device | Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Successful Outcomes (<5-point Decrease in FACT-NTX From Baseline) | The primary endpoint is the change in FACT NTX at 12 weeks from the start of chemotherapy. The change in FACT NTX will be dichotomized into a good outcome (change in FACT NTX less than 5 from baseline to week 12) versus a poor outcome (change in FACT NTX greater than or equal to 5 from baseline to week 12). The FACT-NTX subscale includes 11 items, each of which is divided into 5 scoring levels: 0, 1, 2, 3, 4, and a total score of 44. The scale is graded 0-4. A low score indicates a good effect. This change in FACT-NTX scale score indicates the proportion of patients with successful outcomes. | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NCI-CTCAE Grade for CIPN | National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) is a subjective method to evaluate CIPN which is performed by a healthcare professional. The patient's peripheral sensory neuropathy, peripheral motor neuropathy, dysesthesia, paresthesia and neuralgia will be graded on a scale of 1 to 5 depending on severity with 1 indicating a better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Accordino, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38060077 | Derived | Accordino MK, Lee S, Leu CS, Levin B, Trivedi MS, Crew KD, Kalinsky K, Raghunathan R, Faheem K, Harden E, Taboada A, de Oliveira BD, Larson E, Franks L, Honan E, Law C, Hershman DL. Randomized adaptive selection trial of cryotherapy, compression therapy, and placebo to prevent taxane-induced peripheral neuropathy in patients with breast cancer. Breast Cancer Res Treat. 2024 Feb;204(1):49-59. doi: 10.1007/s10549-023-07172-y. Epub 2023 Dec 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cryotherapy | Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks. Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities. |
| FG001 | Compression Therapy | Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks. Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. |
| FG002 | Control Arm (Loose Glove/Sock) | Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks. Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cryotherapy | Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks. Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Proportion of Patients With Successful Outcomes (<5-point Decrease in FACT-NTX From Baseline) | The primary endpoint is the change in FACT NTX at 12 weeks from the start of chemotherapy. The change in FACT NTX will be dichotomized into a good outcome (change in FACT NTX less than 5 from baseline to week 12) versus a poor outcome (change in FACT NTX greater than or equal to 5 from baseline to week 12). The FACT-NTX subscale includes 11 items, each of which is divided into 5 scoring levels: 0, 1, 2, 3, 4, and a total score of 44. The scale is graded 0-4. A low score indicates a good effect. This change in FACT-NTX scale score indicates the proportion of patients with successful outcomes. | Posted | Number | 95% Confidence Interval | Proportion of Patients | Baseline, 12 weeks |
|
Up to 24 weeks
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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 | Cryotherapy | Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks. Cryotherapy: Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Accordino, MD | Columbia University Irving Medical Center | 646-317-4692 | mkg2134@cumc.columbia.edu |
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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 | Mar 2, 2021 | Apr 25, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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The preferred intervention can be selected during the ongoing enrollment as soon as the pre-specified selection criteria are met, and further enrollment will cease.
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|
| Compression Therapy | Device | Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. |
|
| Loose glove/sock | Device | Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. |
|
| Baseline, 12, and 24 weeks |
| Change in Nail Toxicity | The number of participants with a change in cutaneous toxicity and onycholysis will be assessed by a healthcare professional using the National Cancer Institute Common Toxicity Criteria (Version 2), specifically nail changes. Grade 1 includes discoloration, ridging (koilonychia), or pitting of the nails and Grade 2 is partial or complete loss of nail(s) or pain in the nail beds. A higher grade indicates more nail toxicity. | Baseline, 12 weeks, 24 weeks |
| Comfort With Intervention Scale Score | Comfort with the study intervention will be assessed on a 4-point scale, (0=dissatisfied; 1=not satisfied; 2=satisfied; 3=very satisfied) with 3 indicating a better outcome. | Up to 24 weeks |
| Vibration Perception and Disappearance Threshold | Study participants will be assessed for development of sensory neurological dysfunction. Vibration perception will be assessed using a tuning fork. Vibration threshold will be tested on the bilateral dorsum of the distal interphalangeal joint of the index finger and dorsum of the interphalangeal joint of the hallux. Subjects will be asked to indicate when the vibration stimulus is initially felt (perception threshold) and when the stimulus disappears (disappearance threshold.) The vibration perception threshold is the average of three paired measurements. | Up to 24 weeks |
| Subjects Perceived Pain and Pressure Using Neuropen Test | Evaluation of other sensory endpoints including touch, pressure and pain will be evaluated using a Neuropen. Touch and pressure sensation will be assessed using a 10-g monofilament on the subject's dominant foot. Pain and subjective sharpness sensation will be assessed using the Neuropen on the dominant foot. The spring mechanism is calibrated to exert a force of 40 grams to help identify subjects with loss of pain sensation. Ten points on the foot are tested. If the participant detects pain and pressure on less than 8 points, pain and pressure perception are considered diminished. Perception on 8 points of the foot or greater is considered a better outcome. | Up to 24 weeks |
| Average Time to Complete 'Timed Get up and go' Test | The 'timed get up and go' test is a rapid and widely used clinical performance-based measure of lower extremity function, mobility, and fall risk. Subjects are asked to stand up from a standard chair (seat height between 44 and 47 cm), walk a distance of 3 m (marked on the floor) at a comfortable pace, turn, walk back and sit down. Time will be measured in seconds. Shorter times indicate better performance. | Up to 24 weeks |
| Tandem and Unipedal Stance Test | Balance will be assessed using the tandem and unipedal stance test. In this assessment, the subject stands with one foot in front of the other (heel to toe) (30 seconds), then on one leg with: eyes open (60 seconds), eyes closed (30 seconds), and eyes open with head rotation (30 seconds) with arms held comfortably at the side. The test was accepted failure when the stance foot shifted in any way or the nonstance foot touched the ground. Tests are recorded as achieved (yes) or not achieved (no). | Up to 24 weeks |
| Adherence to Study Intervention | The number of participants who adhered to the intervention. Adherence is defined as wearing the assigned gloves and socks for greater than or equal to 80% of infusions. | Up to 24 weeks |
| BG001 | Compression Therapy | Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks. Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. |
| BG002 | Control Arm (Loose Glove/Sock) | Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks. Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number docetaxel of treatments before baseline | Mean | Standard Deviation | treatments |
|
| OG001 | Compression Therapy | Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks. Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. |
| OG002 | Control Arm (Loose Glove/Sock) | Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks. Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. |
|
|
| Secondary | Change in NCI-CTCAE Grade for CIPN | National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) is a subjective method to evaluate CIPN which is performed by a healthcare professional. The patient's peripheral sensory neuropathy, peripheral motor neuropathy, dysesthesia, paresthesia and neuralgia will be graded on a scale of 1 to 5 depending on severity with 1 indicating a better outcome. | The numbers analyzed at the each of the respective timepoints are the number of participants from which the data was collected. | Posted | Count of Participants | Participants | Baseline, 12, and 24 weeks |
|
|
|
| Secondary | Change in Nail Toxicity | The number of participants with a change in cutaneous toxicity and onycholysis will be assessed by a healthcare professional using the National Cancer Institute Common Toxicity Criteria (Version 2), specifically nail changes. Grade 1 includes discoloration, ridging (koilonychia), or pitting of the nails and Grade 2 is partial or complete loss of nail(s) or pain in the nail beds. A higher grade indicates more nail toxicity. | The numbers analyzed at the each of the respective timepoints are the number of participants from which the data was collected. | Posted | Count of Participants | Participants | Baseline, 12 weeks, 24 weeks |
|
|
|
| Secondary | Comfort With Intervention Scale Score | Comfort with the study intervention will be assessed on a 4-point scale, (0=dissatisfied; 1=not satisfied; 2=satisfied; 3=very satisfied) with 3 indicating a better outcome. | The numbers analyzed at the each of the respective timepoints are the number of participants from which the data was collected. | Posted | Count of Participants | Participants | Up to 24 weeks |
|
|
|
| Secondary | Vibration Perception and Disappearance Threshold | Study participants will be assessed for development of sensory neurological dysfunction. Vibration perception will be assessed using a tuning fork. Vibration threshold will be tested on the bilateral dorsum of the distal interphalangeal joint of the index finger and dorsum of the interphalangeal joint of the hallux. Subjects will be asked to indicate when the vibration stimulus is initially felt (perception threshold) and when the stimulus disappears (disappearance threshold.) The vibration perception threshold is the average of three paired measurements. | Posted | Mean | Standard Deviation | Seconds | Up to 24 weeks |
|
|
|
| Secondary | Subjects Perceived Pain and Pressure Using Neuropen Test | Evaluation of other sensory endpoints including touch, pressure and pain will be evaluated using a Neuropen. Touch and pressure sensation will be assessed using a 10-g monofilament on the subject's dominant foot. Pain and subjective sharpness sensation will be assessed using the Neuropen on the dominant foot. The spring mechanism is calibrated to exert a force of 40 grams to help identify subjects with loss of pain sensation. Ten points on the foot are tested. If the participant detects pain and pressure on less than 8 points, pain and pressure perception are considered diminished. Perception on 8 points of the foot or greater is considered a better outcome. | The numbers analyzed at the each of the respective timepoints are the number of participants from which the data was collected. | Posted | Count of Participants | Participants | Up to 24 weeks |
|
|
|
| Secondary | Average Time to Complete 'Timed Get up and go' Test | The 'timed get up and go' test is a rapid and widely used clinical performance-based measure of lower extremity function, mobility, and fall risk. Subjects are asked to stand up from a standard chair (seat height between 44 and 47 cm), walk a distance of 3 m (marked on the floor) at a comfortable pace, turn, walk back and sit down. Time will be measured in seconds. Shorter times indicate better performance. | Posted | Mean | Standard Deviation | Seconds | Up to 24 weeks |
|
|
|
| Secondary | Tandem and Unipedal Stance Test | Balance will be assessed using the tandem and unipedal stance test. In this assessment, the subject stands with one foot in front of the other (heel to toe) (30 seconds), then on one leg with: eyes open (60 seconds), eyes closed (30 seconds), and eyes open with head rotation (30 seconds) with arms held comfortably at the side. The test was accepted failure when the stance foot shifted in any way or the nonstance foot touched the ground. Tests are recorded as achieved (yes) or not achieved (no). | The numbers analyzed at the each of the respective timepoints and assessments are the number of participants from which the data was collected. | Posted | Count of Participants | Participants | Up to 24 weeks |
|
|
|
| Secondary | Adherence to Study Intervention | The number of participants who adhered to the intervention. Adherence is defined as wearing the assigned gloves and socks for greater than or equal to 80% of infusions. | Posted | Count of Participants | Participants | Up to 24 weeks |
|
|
|
| 0 |
| 20 |
| 3 |
| 20 |
| 16 |
| 20 |
| EG001 | Compression Therapy | Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks. Compression Therapy: Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. | 2 | 22 | 3 | 22 | 20 | 22 |
| EG002 | Control Arm (Loose Glove/Sock) | Men or women over the age of 18 with a history of stage I-III breast cancer and is scheduled to receive adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks. Loose glove/sock: Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. | 1 | 21 | 1 | 21 | 19 | 21 |
| Neutrophil count decreased | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Skin infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Thromboembolic event | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Confusion | Psychiatric disorders | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Fever | General disorders | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Edema limbs | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Administration site conditions | General disorders | Non-systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Nail discoloration | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Nail loss | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Non-systematic Assessment |
|
| Pain | General disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders - Other | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Skin and subcutaneous tissue disorders - Other | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Hot flashes | Vascular disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrointestinal disorders - Other | Gastrointestinal disorders | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Nail ridging | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| Stage increased |
|
| Stage stayed the same |
|
| Week 24 |
|
|
| Stage increased |
|
| Stage stayed the same |
|
| Week 24 |
|
|
| Not Satisfied |
|
| Satisfied |
|
| Very Satisfied |
|
| Week 24 |
|
|
|
| Week 24: Hand Perception |
|
| Week 24: Foot Perception |
|
| Week 12: Hand Disapperance |
|
| Week 12: Foot Disappearance |
|
| Week 24: Hand Disappearance |
|
| Week 24: Foot Disappearance |
|
| >=8 points of the foot |
|
| Week 12: Pain |
|
|
| Week 24: Touch and Pressure |
|
|
| Week 24: Pain |
|
|
|
| Yes |
|
| Week 12: One leg, eyes closed |
|
|
| Week 12: One leg, eyes open, rotated |
|
|
| Week 24: One leg, eyes open |
|
|
| Week 24: One leg, eyes closed |
|
|
| Week 24: One leg, eyes open, rotated |
|
|