MC-5A for Chemotherapy Induced Peripheral Neuropathy

Phase 2

Completed

• Conditions: Neuropathy, Paraneoplastic
• Interventions: Device: MC-5A; Drug: Sham device

• Registration Number: NCT01261780
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-16
• Study Start: 2011-04
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Results First Submitted: 2017-06-20
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-06
• Results First Posted: 2017-11-06
• Last Update Submitted: 2019-11-14
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MC-5A treatment	MC-5A	MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.
Sham device	Sham device	Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days

Primary Outcome Measures

Name	Time	Method
Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT)	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.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Up to 3 months	The number of participants experiencing adverse events, as defined by CTCAE

Trial Locations

Locations (1)

University of Wisconsin Comprehensive Cancer Center; 🇺🇸 Madison, Wisconsin, United States