MC-5A for Chemotherapy Induced Peripheral Neuropathy

Study Overview
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Brief Summary
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Painful chemotherapy induced peripheral neuropathy (CIPN) is a common complication of cancer therapy with few treatment options. CIPN is a complex side effect that varies between individuals and can be difficult to describe, difficult to treat and can significantly effect quality of life for patients. The purpose of this study is to determine if patients with painful CIPN will have a decrease in pain scores after treatment with the MC-5A device.

Official Title
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Treatment of Painful Chemotherapy -Induced Peripheral Neuropathy With the MC-5A Pain Therapy Medical Device, a Randomized, Double-Blind, Sham-Controlled Clinical Trial

Conditions
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Neuropathy, Paraneoplastic

Intervention / Treatment
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* Device: MC-5A
* Drug: Sham device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: painful peripheral neuropathy resulting from chemotherapy pain must be present for minimum of 6 months must be able to read/understand English stable analgesics regimens allowed (no change for past 7 days) Exclusion Criteria: painful peripheral neuropathy that is not the result of chemotherapy pregnant women patients unable to wean off anti-epileptics patients currently receiving chemotherapy known to cause peripheral neuropathy patients with pacemakers or implanted defibrillators patients with vena cava or aneurysm clips patients with a history of epilepsy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham device<br>Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days | Drug: Sham device<br>* Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)<br>* Other names: TRA-1;|
| Active Comparator: MC-5A treatment<br>MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days. | Device: MC-5A<br>* 45 minutes daily x 10 treatments (given over the course of 2 weeks)<br>* Other names: Scrambler therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT) | Pain levels will be compared as measured by changes in mVAS, and quantified and tested for normal distribution. If normally distributed, parametric test (i.e., two-sample t-test) will be used; p-values <0.05 will be considered statistically significant. If changes in mVAS are not normally distributed, non-parametric testing such as Wilcoxon rank-sum will be performed. VAS is measured at 3 time points. mVAS and deficits scale are used to obtain continuous quantitative information about positive and negative sensory phenomena during application of QSPT stimulation. Patients provide rating of positive sensory phenomena using mVAS if the stimulus at the pain test site is increased or painful when compared to normal control site. Rating on mVAS is obtained by instructing the patient to pull out the mechanical scale with millimeters (looks like a slide ruler) to reflect intensity of any painful sensation on a scale of 0 - 10, with 10 being the worst. Score = Visit - Baseline. | Baseline, Visit 1 (Day 1), Vist 10 (Day 10), and End of Study (Week 12, +/- 2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | The number of participants experiencing adverse events, as defined by CTCAE | Up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuropathy,paraneoplastic, paraneoplastic peripheral neuropathy, pain, hyperalgesia