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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00090611 | Other Identifier | JHM IRB |
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| Name | Class |
|---|---|
| Axogen Corporation | INDUSTRY |
| Johns Hopkins University | OTHER |
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Problem: A significant proportion of patients with cancer experience symptoms of sensory, motor or autonomic nerve damage from chemotherapy known as chemotherapy-induced peripheral neuropathy (CIPN). CIPN is a major dose-limiting toxicity of many chemotherapeutic regimens. Little is known about the natural history of CIPN, and the early detection and quantification of CIPN is a significant challenge.
Design: The investigators propose a cohort study to evaluate the performance of the Pressure-Specified Sensory Device TM (PSSD) in assessing CIPN associated with various common chemotherapy regimens. The proposed study will examine peripheral nerve function before, during, and after chemotherapy treatment. Peripheral neuropathy will be assessed using the PSSD, the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CIPN-20, and the Michigan Neuropathy Screening Instrument (MNSI). These are all established and validated methods to screen for a variety of conditions that cause peripheral neuropathy.
Hypotheses: The investigators hypothesize that the PSSD will be a sensitive and specific tool for measuring CIPN. The onset of CIPN as detected by the PSSD will be compared with other screening modalities including the EORTC QLQ-CIPN20 and the MNSI.
Importance: The development of CIPN often goes unnoticed until symptoms are bothersome. Having an objective tool in the care team's armament to screen for CIPN could have a significant public health impact.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving neurotoxic chemotherapy regimen | Patients receiving chemotherapy regimens involving known neurotoxic agents. Common neurotoxic agents include vinca alkaloids (ie. vincristine), taxanes (ie. Taxol), platins (ie. Oxaliplatin) and some other drugs beyond these categories (ie. Bortezomib). Patients will have neurosensory function of hands and feet tested with the non-invasive Pressure-Specified Sensory Device, as well as completing two questionnaires at each visit:
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| Patients receiving non-neurotoxic chemotherapy regimen | Patients receiving chemotherapy regimens involving agents with negligible or doubtful risk of neurotoxicity. Patients will have neurosensory function of hands and feet tested with the non-invasive Pressure-Specified Sensory Device, as well as completing two questionnaires at each visit:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurosensory testing with Pressure-Specified Sensory Device | Device | Patients will have neurosensory function of hands and feet tested with the non-invasive Pressure-Specified Sensory Device. |
| Measure | Description | Time Frame |
|---|---|---|
| Pressure-Specified Sensory Device (PSSD) Score | The PSSD Sensory Score is based on 1-point static and 2-point static pressure thresholds and 2- point distances. Cutaneous pressure thresholds and inter-prong distances are reported by the PSSD and determined to be normal or abnormal at a 99% confidence limit based on age (</= 45, or >45). These results correlate to a grading scheme which combines 1- and 2-point static pressure threshold with 2-point distance. An increase of greater than or equal to 1 grade from baseline as measured with the PSSD will be considered a meaningful change. The grading scale integrates normative data for each PSSD testing site. For the index finger pulp, big toe pulp, and first dorsal webspace of the foot, the grading scale goes from 0 to 5 inclusive. For the little finger pulp, the grading scale goes from 0 to 4 inclusive. | up to 2 months post-intervention |
| European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire module CIPN20 (EORTC QLQ-CIPN20) | The CIPN20 module of the EORTC QLQ, is a validated twenty item patient-reported outcomes questionnaire used to quantify symptoms of Chemotherapy-Induced Peripheral Neuropathy. Those whose score is greater than or equal to 0.5 standard deviation increase from baseline will be considered positive for CIPN using the EORTC QLQ-CIPN20. | up to 2 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Michigan Neuropathy Screening Instrument (MNSI) patient reported outcomes portion. | The patient reported outcomes portion of the MNSI will be used as a secondary measure, where a higher score indicates more neuropathic symptoms. | up to 2 months post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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Cohorts will be selected from patients receiving inpatient or outpatient chemotherapy at Johns Hopkins Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Nina Wagner-Johnston, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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