Nerve excitability testing for cisplatin-related peripheral neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: Kho5@bidmc.harvard.edu
• Phone: 617-667-1665

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.