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Recruiting Not applicable NCT07095998

Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy

No applicable phase (e.g. observational)
Conditions: Peripheral Neuropathy Due to Chemotherapy Peripheral Neuropathy Neurotoxicity Syndromes Neuropathy

Sponsor: Ka-Wai Ho

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Threshold Tracking Nerve Conduction Studies
DIAGNOSTIC_TEST
Locations 2
United States (2)
Beth Israel Deaconess Medical Center
Boston , Massachusetts
Dana-Farber Cancer Institute
Boston , Massachusetts
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
31.01.2026
Completion date
31.12.2028
Registry ID
NCT07095998
Source
clinicaltrials.gov
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