Neuropathy, Neurotoxicity Syndromes, Peripheral Neuropathy, Peripheral Neuropathy Due to Chemotherapy
Conditions
Keywords
Peripheral Neuropathy Due to Chemotherapy, Peripheral Neuropathy, Neurotoxicity Syndromes, Neuropathy
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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTThreshold 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.
Sponsors
Ka-Wai Ho
Dana-Farber Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of change in Nerve Excitability in comparison to baseline nerve excitability. | 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. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who develop neuropathy symptoms as assessed by CTCAE v. 5.0. | 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. | The Wilcoxon signed rank test (two tailed) will be used to compared measurements at these time points. |
Countries
United States
Contacts
CONTACTKa-Wai Ho, MD
PRINCIPAL_INVESTIGATORKa-Wai Ho, MD
Beth Israel Deaconess Medical Center
PRINCIPAL_INVESTIGATORTamar Berger, MD PhD
Dana-Farber Cancer Institute
Outcome results
None listed