Nerve Excitability in Cisplatin-Induced Peripheral Neuropathy

ConditionsPeripheral Neuropathy Due to Chemotherapy Peripheral Neuropathy Neurotoxicity Syndromes Neuropathy

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorKa-Wai Ho

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Threshold Tracking Nerve Conduction Studies
Diagnostic test
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Cohort A: Participants Without Cisplatin-Induced Peripheral NeuropathyExperimental treatment 1 intervention

Group B: Cohort B: Participants with Cisplatin-Induced Peripheral NeuropathyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Presence of change in Nerve Excitability in comparison to baseline nerve excitability.

Nerve excitability will be assessed via Threshold Tracking Nerve Conduction Study (TTNCS). Excitability parameters collected will include refractoriness, superexcitability, extent of threshold change in threshold electrotonus (hyperpolarizing 90-100ms). A composite excitability score is calculated to assess overall change in excitability parameters, all of which are weighted equally (Park, S.B., Lin, C.S.Y., Kiernan, M.C. Nerve Excitability Assessment in Chemotherapy-induced Neurotoxicity.J. Vis. Exp. (62), e3439, doi:10.3791/3439 (2012).

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 outcomes

Number of participants who develop neuropathy symptoms as assessed by CTCAE v. 5.0.

The Wilcoxon signed rank test (two tailed) will be used to compared measurements at these time points.

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.

Sponsors and contacts

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Ka-Wai Ho

Lead sponsor

Beth Israel Deaconess Medical Center

Sponsor institution

Dana-Farber Cancer Institute

Collaborator

Source ClinicalTrials.gov

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