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.
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.
Eligibility
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.
