Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy

NCT07095998 | Recruiting

• 1 other identifier: 24-766
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Presence of change in Nerve Excitability in comparison to baseline nerve excitability.

  Nerve excitability will be assessed via Threshold Tracking Nerve Conduction Study (TTNCS). Excitability parameters collected will include refractoriness, superexcitability, extent of threshold change in threshold electrotonus (hyperpolarizing 90-100ms). A composite excitability score is calculated to assess overall change in excitability parameters, all of which are weighted equally (Park, S.B., Lin, C.S.Y., Kiernan, M.C. Nerve Excitability Assessment in Chemotherapy-induced Neurotoxicity.J. Vis. Exp. (62), e3439, doi:10.3791/3439 (2012).

  For Arm A, the time frame is at baseline and within 24 weeks of cisplatin initiation. For Arm B, the time frame is during the TTNCS procedure.

Secondary Outcomes (1)

• Number of participants who develop neuropathy symptoms as assessed by CTCAE v. 5.0.

  For Arm A, peripheral neuropathy symptoms will be assessed at baseline and the time of the development of Cis-PN symptoms over the course of 24 weeks. For Arm B, symptoms will be assessed immediately before the TTNCS procedure.

Study Arms (2)

Cohort A: Participants Without Cisplatin-Induced Peripheral Neuropathy

EXPERIMENTAL

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

Diagnostic Test: Threshold Tracking Nerve Conduction Studies

Cohort B: Participants with Cisplatin-Induced Peripheral Neuropathy

EXPERIMENTAL

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

Diagnostic Test: Threshold Tracking Nerve Conduction Studies

Interventions

Threshold Tracking Nerve Conduction Studies DIAGNOSTIC_TEST

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.

Also known as: TTNC, TTNCS

Cohort A: Participants Without Cisplatin-Induced Peripheral Neuropathy; Cohort B: Participants with Cisplatin-Induced Peripheral Neuropathy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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;

Sponsors & Collaborators

• Ka-Wai Ho: lead
• Dana-Farber Cancer Institute: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Neurotoxicity Syndromes

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Ka-Wai Ho, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• Tamar Berger, MD PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ka-Wai Ho, MD

CONTACT

617-667-1665; Kho5@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: July 31, 2025
• Study Start: January 31, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu

Locations

US (2)