MC-5A for Chemotherapy Induced Peripheral Neuropathy
|ClinicalTrials.gov Identifier: NCT01261780|
Recruitment Status : Completed
First Posted : December 16, 2010
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Neuropathy, Paraneoplastic||Device: MC-5A Drug: Sham device||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Treatment of Painful Chemotherapy -Induced Peripheral Neuropathy With the MC-5A Pain Therapy Medical Device, a Randomized, Double-Blind, Sham-Controlled Clinical Trial|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
Sham Comparator: Sham device
Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days
Drug: Sham device
Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)
Other Name: TRA-1
Active Comparator: MC-5A treatment
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)
Other Name: Scrambler therapy
- Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT) [ Time Frame: Baseline, Visit 1 (Day 1), Vist 10 (Day 10), and End of Study (Week 12, +/- 2 weeks) ]
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.
- Adverse Events [ Time Frame: Up to 3 months ]The number of participants experiencing adverse events, as defined by CTCAE
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261780
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Tony Campbell||University of Wisconsin, Madison|