MC-5A for Chemotherapy Induced Peripheral Neuropathy
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Change in Visual Analog Scale pre/post treatment [ Time Frame: baseline, before/after each treatment, and 3 months after treatment ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: Daily with each treatment and at end of 3 month follow up period ] [ Designated as safety issue: Yes ]adverse events according to CTCAE
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||November 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
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