Nerve excitability testing for cisplatin-related peripheral neuropathy

Evaluation of Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy

This study will see if specialized nerve excitability tests (TTNCS) can detect early nerve changes in adults starting cisplatin or who recently finished cisplatin and have peripheral neuropathy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beth Israel Deaconess Medical Center (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Boston, Massachusetts and 1 other locations)
• Trial ID: NCT07095998 on ClinicalTrials.gov

What this trial studies

Participants will undergo threshold tracking nerve conduction studies (TTNCS), standard nerve conduction studies, blood tests, questionnaires, and neurological exams to measure nerve excitability changes. The protocol enrolls two cohorts: people about to begin cisplatin-based chemotherapy without prior neuropathy, and people who finished cisplatin within the past three months and currently have cisplatin-induced neuropathy. About 60 participants are expected, and testing occurs during in-clinic visits at the Boston sites. The goal is to map excitability parameter changes that could serve as early markers of cisplatin neurotoxicity and clarify underlying pathophysiology.

Who should consider this trial

Good fit: Adults aged 18 or older who either will begin cisplatin-based chemotherapy and have no pre-existing neuropathy (Cohort A) or who completed cisplatin within the past 3 months and currently have cisplatin-induced peripheral neuropathy (Cohort B).

Not a fit: People with pre-existing or hereditary neuropathies, those receiving other neuropathy-causing chemotherapies, patients with cardiac/spinal stimulators, pregnant or breastfeeding people, and those unable to complete study questionnaires are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could enable earlier detection of cisplatin neurotoxicity and help clinicians adjust treatment to reduce long-term nerve damage.

How similar studies have performed: Related nerve excitability and threshold-tracking techniques have been used in other chemotherapy neuropathy research and have shown promise for detecting early axonal dysfunction, though they are not yet widely adopted as standard diagnostics.

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.

Where this trial is running

Boston, Massachusetts and 1 other locations

• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Ka-Wai Ho, MD — Beth Israel Deaconess Medical Center
• Study coordinator: Ka-Wai Ho, MD

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