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MC-5A for Chemotherapy Induced Peripheral Neuropathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01261780
First Posted: December 16, 2010
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
December 9, 2010
December 16, 2010
June 20, 2017
November 6, 2017
November 6, 2017
April 2011
September 2012   (Final data collection date for primary outcome measure)
Change in Mechanical Visual Analog Scale (mVAS) Using Quantitative Sensory Pain Testing (QSPT) [ Time Frame: 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.

Change in Visual Analog Scale pre/post treatment [ Time Frame: baseline, before/after each treatment, and 3 months after treatment ]
Complete list of historical versions of study NCT01261780 on ClinicalTrials.gov Archive Site
Adverse Events [ Time Frame: Up to 3 months ]
The number of participants experiencing adverse events, as defined by CTCAE
Adverse Events [ Time Frame: Daily with each treatment and at end of 3 month follow up period ]
adverse events according to CTCAE
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
Intervention Model: Parallel Assignment
Masking: Triple (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
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)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01261780
OS10328
Yes
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
October 2017

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