Recruiting

Cisplatin

Sponsor:

Ka-Wai Ho

Code:

NCT07095998

Conditions

Peripheral Neuropathy Due to Chemotherapy

Peripheral Neuropathy

Neurotoxicity Syndromes

Neuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Threshold Tracking Nerve Conduction Studies

Study Details

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.

Conditions

Peripheral Neuropathy Due to Chemotherapy

Peripheral Neuropathy

Neurotoxicity Syndromes

Neuropathy

Study ID

NCT07095998

Start date

Jan 31, 2026

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 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

experimental: 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

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.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Ka-Wai Ho, MD

617-667-1665Kho5@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Ka-Wai Ho, MD

617-667-1665kho5@bidmc.harvard.edu

Principal Investigator:

Ka-Wai Ho, MD

More Information

Sponsor

Ka-Wai Ho

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Keywords

  • Peripheral Neuropathy Due to Chemotherapy
  • Peripheral Neuropathy
  • Neurotoxicity Syndromes
  • Neuropathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ka-Wai Ho on 2026-04-22.