Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy

Official title

Evaluation of Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy

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.

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.

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.

Primary outcome measures

• Presence of change in Nerve Excitability in comparison to baseline nerve excitability. [Time frame: 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 outcome measures (1)

• Number of participants who develop neuropathy symptoms as assessed by CTCAE v. 5.0. [Time frame: 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.]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 2 centers

• Beth Israel Deaconess Medical Center — Boston
• Dana-Farber Cancer Institute — Boston

Identifiers

NCT: NCT07095998 · 24-766

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗