Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy

NCT ID: NCT07095998

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2027-12-31

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.

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cohort A: Participants Without Cisplatin-Induced Peripheral Neuropathy

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

Group Type: EXPERIMENTAL

Threshold Tracking Nerve Conduction Studies

Intervention Type: 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.

Cohort B: Participants with Cisplatin-Induced Peripheral Neuropathy

30 participants with cis-PN symptoms will be enrolled and will complete the following:

-One-time visit with neurological exams and conduction studies

Group Type: EXPERIMENTAL

Threshold Tracking Nerve Conduction Studies

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

TTNC; TTNCS

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: collaborator

Ka-Wai Ho

OTHER

Sponsor Role: lead

Responsible Party

Ka-Wai Ho

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ka-Wai Ho, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Tamar Berger, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Central Contacts

Ka-Wai Ho, MD

Role: CONTACT

Kho5@bidmc.harvard.edu

617-667-1665

Facility Contacts

Ka-Wai Ho, MD

Role: primary

kho5@bidmc.harvard.edu

617-667-1665

Tamar Berger, MD, PhD

Role: primary

Tamar_berger@dfci.harvard.edu

617-632-6140

Other Identifiers

24-766

Identifier Type: -

Identifier Source: org_study_id