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NCT07095998

Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy

Sponsor: Ka-Wai Ho

View on ClinicalTrials.gov

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.

Official title: Evaluation of Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-08

Completion Date

2027-12-31

Last Updated

2025-07-31

Healthy Volunteers

Conditions

Peripheral Neuropathy Due to Chemotherapy Peripheral Neuropathy Neurotoxicity Syndromes Neuropathy

Interventions

DIAGNOSTIC_TEST

Threshold Tracking Nerve Conduction Studies

Measurement of nerve excitability parameters, including response to sub-threshold pre-pulses and other stimuli. The DS5 0 Isolated Bipolar Constant Current Stimulator is a non-invasive, non-therapeutic device that provides controlled electrical stimuli for detailed function assessment of the superficial radial, superficial peroneal, ulnar, and sural nerves.

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.

Locations (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute