MC-5A for Chemotherapy Induced Peripheral Neuropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by University of Wisconsin, Madison.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01261780
First received: December 9, 2010
Last updated: October 8, 2012
Last verified: October 2012

December 9, 2010
October 8, 2012
April 2011
June 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01261780 on ClinicalTrials.gov Archive Site
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
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
November 2012
June 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01261780
OS10328
Yes
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Not Provided
University of Wisconsin, Madison
October 2012

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