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MC-5A for Chemotherapy Induced Peripheral Neuropathy

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.
 
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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Neuropathy, Paraneoplastic Device: MC-5A Drug: Sham device Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Painful Chemotherapy -Induced Peripheral Neuropathy With the MC-5A Pain Therapy Medical Device, a Randomized, Double-Blind, Sham-Controlled Clinical Trial
Study Start Date : April 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Sham device
Sham therapy device to area of painful chemotherapy induced peripheral neuropathy (CIPN) for 45 minutes daily x 10 days
 Drug: Sham device
Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)
Other Name: TRA-1
Active Comparator: MC-5A treatment
MC-5A therapy to the area of painful CIPN for 45 minutes daily for a total of 10 days.
 Device: MC-5A
45 minutes daily x 10 treatments (given over the course of 2 weeks)
Other Name: Scrambler therapy


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to 3 months ]
    The number of participants experiencing adverse events, as defined by CTCAE


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01261780


Locations
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United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Tony Campbell University of Wisconsin, Madison
More Information
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Additional Information:

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01261780    
Other Study ID Numbers: 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 )
First Posted: December 16, 2010    Key Record Dates
Results First Posted: November 6, 2017
Last Update Posted: December 2, 2019
Last Verified: October 2017
Keywords provided by University of Wisconsin, Madison:
neuropathy,paraneoplastic
paraneoplastic peripheral neuropathy
pain
hyperalgesia
Additional relevant MeSH terms:
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Paraneoplastic Polyneuropathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
 Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Neurodegenerative Diseases
Polyneuropathies