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MC-5A for Chemotherapy Induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT01261780
Recruitment Status : Completed
First Posted : December 16, 2010
Results First Posted : November 6, 2017
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE December 9, 2010
First Posted Date  ICMJE December 16, 2010
Results First Submitted Date  ICMJE June 20, 2017
Results First Posted Date  ICMJE November 6, 2017
Last Update Posted Date December 2, 2019
Study Start Date  ICMJE April 2011
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 15, 2010)
Change in Visual Analog Scale pre/post treatment [ Time Frame: baseline, before/after each treatment, and 3 months after treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2017)
Adverse Events [ Time Frame: Up to 3 months ]
The number of participants experiencing adverse events, as defined by CTCAE
Original Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2010)
Adverse Events [ Time Frame: Daily with each treatment and at end of 3 month follow up period ]
adverse events according to CTCAE
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MC-5A for Chemotherapy Induced Peripheral Neuropathy
Official Title  ICMJE Treatment of Painful Chemotherapy -Induced Peripheral Neuropathy With the MC-5A Pain Therapy Medical Device, a Randomized, Double-Blind, Sham-Controlled Clinical Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neuropathy, Paraneoplastic
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2015)
14
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2010)
40
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01261780
Other Study ID Numbers  ICMJE OS10328
2010-0361 ( Other Identifier: Institutional Review Board )
NCI-2012-00075 ( Registry Identifier: NCI Trial ID )
A534260 ( Other Identifier: UW Madison )
SMPH\MEDICINE\HEM-ONC ( Other Identifier: UW Madison )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tony Campbell University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date October 2017

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