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MC-5A for Chemotherapy Induced Peripheral Neuropathy

This study has been completed.
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: December 9, 2010
Last updated: July 19, 2016
Last verified: July 2016

December 9, 2010
July 19, 2016
April 2011
September 2012   (Final data collection date for primary outcome measure)
Change in Visual Analog Scale pre/post treatment [ Time Frame: baseline, before/after each treatment, and 3 months after treatment ]
Same as current
Complete list of historical versions of study NCT01261780 on Archive Site
Adverse events [ Time Frame: Daily with each treatment and at end of 3 month follow up period ]
adverse events according to CTCAE
Same as current
Not Provided
Not Provided
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

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.

Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neuropathy, Paraneoplastic
  • Device: MC-5A
    45 minutes daily x 10 treatments (given over the course of 2 weeks)
    Other Name: Scrambler therapy
  • Drug: Sham device
    Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)
    Other Name: TRA-1
  • Sham Comparator: Sham device
    Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days
    Intervention: Drug: Sham device
  • Active Comparator: MC-5A treatment
    MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.
    Intervention: Device: MC-5A
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2012
September 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Tony Campbell University of Wisconsin, Madison
University of Wisconsin, Madison
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP