Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy

Ka-Wai Ho

Status: Not yet enrolling

Conditions: Neurotoxicity Syndromes; Peripheral Neuropathy; Peripheral Neuropathy Due to Chemotherapy; Neuropathy

Treatments: Diagnostic Test: Threshold Tracking Nerve Conduction Studies

Study type: Interventional

Funder types: Other

Identifiers

NCT07095998

24-766

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Cohort A: Participants Without Cisplatin-Induced Peripheral Neuropathy

Experimental group

Description:

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

Treatment:

Diagnostic Test: Threshold Tracking Nerve Conduction Studies

Cohort B: Participants with Cisplatin-Induced Peripheral Neuropathy

Experimental group

Description:

30 participants with cis-PN symptoms will be enrolled and will complete the following: -One-time visit with neurological exams and conduction studies

Treatment:

Diagnostic Test: Threshold Tracking Nerve Conduction Studies