CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 14 enrolled
Drug / intervention
Sham device +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01261780
NCT01261780Phase 2Completed
CompareCT.gov

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

University of Wisconsin, Madison·interventional·Posted Dec 16, 2010·Updated Dec 2, 2019

In Brief

A Phase 2 clinical trial evaluating MC-5A and Sham device for Neuropathy, Paraneoplastic. Completed, enrolled 14 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuropathy, Paraneoplastic
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 16, 2010
Enrollment StartApr 1, 2011
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 15.5 years ago

Interventions

MC-5Adevice

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

Sham devicedrug

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