Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy
Purpose
This study aims to evaluate nerve excitability in participants with cisplatin-induced peripheral neuropathy (cis-PN) using threshold tracking nerve conduction studies (TTNCS). By assessing changes in nerve excitability parameters, the study seeks to enhance understanding of the pathophysiology of cis-PN and identify early markers of neurotoxicity in participants undergoing cisplatin-based chemotherapy.
Conditions
- Peripheral Neuropathy Due to Chemotherapy
- Peripheral Neuropathy
- Neurotoxicity Syndromes
- Neuropathy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Cohort A: - Adults age ≥ 18 who will begin cisplatin-based chemotherapy either alone or in combination with other agents that are not known to cause neuropathy. - Participants must have adequate hematologic parameters to allow chemotherapy.
Exclusion Criteria
Cohort A: - Pre-existing peripheral neuropathy; - Family history of a genetic/familial neuropathy; - Any contraindication for treatment with cisplatin as determined by their primary oncologist; - Chemotherapy regimen combining cisplatin with another known chemotherapy agent that may cause peripheral neuropathy; - Patients with cardiac or spinal stimulating devices; - Women who are pregnant or breastfeeding; - Adults with impaired consent capacity as patients must be able to fill out questionnaires regarding their neuropathy symptoms; - Other medical conditions that in the opinion of the treating physician would make the protocol unreasonably hazardous for the patient; - Patients not considered to be able to comply with the protocol. Inclusion Criteria Cohort B: - Adults age ≥ 18 with a diagnosis of cis-PN. - The last dose of cisplatin must be ≥ 3 months prior to study enrollment. Patients who may have been previously enrolled in Cohort A of this study are eligible to participate in Cohort B if they continue to have cis-PN symptoms 3 months after completion of cisplatin therapy. Exclusion Criteria Cohort B: - Pre-existing peripheral neuropathy; - Family history of a genetic/familiar neuropathy; - History of cisplatin-based regimen combining cisplatin with another known chemotherapy agent that may cause peripheral neuropathy; - Patients with cardiac or spinal stimulating devices; - Women who are pregnant or breastfeeding; - Adults with impaired consent capacity as patients must be able to fill out questionnaires regarding their neuropathy symptoms; - Other medical conditions that in the opinion of the treating physician would make the protocol unreasonably hazardous for the patient; - Patients not considered to be able to comply with the protocol.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Cohort A: Participants Without Cisplatin-Induced Peripheral Neuropathy |
30 participants with no baseline neuropathy symptoms will be enrolled prior to starting cisplatin-based chemotherapy and will complete the following: - Baseline visit with neurological exams and conduction studies - Standard of care chemotherapy infusion (duration may vary depending on the chemotherapy regimen received) - Post-Infusion study visits via phone call (number of visits may vary depending on the chemotherapy regimen received) - In-clinic visit with neurological exams and conduction studies if participants develop cis-PN symptoms --If participants do not develop cis-PN symptoms, participants will be reevaluated 1 month post end of cisplatin treatment - 7-day end of treatment visit via phone call - 1-month post-treatment visit with neurological exams and conduction studies |
|
|
Experimental Cohort B: Participants with Cisplatin-Induced Peripheral Neuropathy |
30 participants with cis-PN symptoms will be enrolled and will complete the following: -One-time visit with neurological exams and conduction studies |
|
Recruiting Locations
Boston, Massachusetts 02215
More Details
- Status
- Recruiting
- Sponsor
- Ka-Wai Ho
Detailed Description
This study aims to evaluate nerve excitability in participants with cisplatin-induced peripheral neuropathy (cis-PN) using threshold tracking nerve conduction studies (TTNCS). By assessing changes in nerve excitability parameters, the study seeks to enhance understanding of the pathophysiology of cis-PN and identify early markers of neurotoxicity in participants undergoing cisplatin-based chemotherapy. Peripheral neuropathy is a sensory disorder where patients feel a burning, tingling, or pins-and-needles sensation in the hands and feet that can lead to oversensitivity or numbness. The U.S. Food and Drug Administration (FDA) has not approved DS5 0 Isolated Bipolar Constant Current Stimulator as a diagnostic tool for Peripheral Neuropathy. The research study procedures include screening for eligibility, in-clinic visits, blood tests, questionnaires, and standard neurological exams called nerve conduction studies and Threshold tracking nerve conduction studies. Participants will be placed into one of the following groups: - Cohort A: Participants without previous treatment with cisplatin and are about to start treatment with Cisplatin. - Cohort B: Participants with previous treatment with cisplatin in the past 3 months (and no longer being treated with cisplatin) and are currently experiencing cisplatin- induced peripheral neuropathy. It is expected that about 60 people will take part in this research study.