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Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days

MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.

45 minutes daily x 10 treatments (given over the course of 2 weeks)

MC-5A

Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)

Sham device

Tony Campbell

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.

MC-5A for Chemotherapy Induced Peripheral Neuropathy

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

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.

The number of participants experiencing adverse events, as defined by CTCAE

University of Wisconsin, Madison

This study uses the CTCAE v.4 definition of adverse event, which does not differ from the clinicaltrials.gov definitions.

Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days

Sham device: Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)

Sham Device

MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.

MC-5A: 45 minutes daily x 10 treatments (given over the course of 2 weeks)

MC-5A Treatment

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The small sample size is subject to type II error. The estimated effect size for MC5A is high: the company estimates 100% of patients will respond. Thus our power calculations suggested a small sample could still detect a difference.

Toby Campbell

Visit 1 (Day 1)

Visit 10 (Day 10)

End of Study (Week 12, +/- 2 weeks)

The number analyzed differs per row as some participants dropped out or did not receive all 10 treatments. For example, on the Sham Device arm, only 4 participants were treated on day 10 but 5 returned for the final visit. Because this was a pilot study, all participant data was analyzed and is included here.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
MC-5A for Chemotherapy Induced Peripheral Neuropathy	NCT01261780	Neuropathy, Par...	MC-5A Sham device	18 Years -	University of Wisconsin, Madison
MC-5A for Chemotherapy Induced Peripheral Neuropathy	NCT01261780	Neuropathy, Par...	MC-5A Sham device	18 Years -	University of Wisconsin, Madison

Spots Global Cancer Trial Database for neuropathy, paraneoplastic