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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: October 12, 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
  Purpose

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 Intervention Phase
Neuropathy, Paraneoplastic Device: MC-5A Drug: Sham device Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Change in Visual Analog Scale pre/post treatment [ Time Frame: baseline, before/after each treatment, and 3 months after treatment ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: Daily with each treatment and at end of 3 month follow up period ]
    adverse events according to CTCAE


Enrollment: 14
Study Start Date: April 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Tony Campbell University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01261780     History of Changes
Other Study ID Numbers: OS10328
First Submitted: December 9, 2010
First Posted: December 16, 2010
Last Update Posted: October 12, 2017
Last Verified: July 2016

Keywords provided by University of Wisconsin, Madison:
neuropathy,paraneoplastic
paraneoplastic peripheral neuropathy
pain
hyperalgesia

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Paraneoplastic Polyneuropathy
Neuromuscular Diseases
Nervous System Diseases
Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Neurodegenerative Diseases
Polyneuropathies