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NCT07095998NARecruiting

Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy

Ka-Wai Ho

Start Date

1/31/2026

Completion Date

12/31/2028

Summary

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DIAGNOSTIC_TEST

Threshold Tracking Nerve Conduction Studies

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Conditions

Peripheral Neuropathy Due to ChemotherapyPeripheral NeuropathyNeurotoxicity SyndromesNeuropathy

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 02215

United States