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MC-5A for Chemotherapy Induced Peripheral Neuropathy

This study is ongoing, but not recruiting participants.
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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: April 2011
Estimated Study Completion Date: November 2012
Primary Completion Date: June 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261780

Locations
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01261780     History of Changes
Other Study ID Numbers: OS10328
Study First Received: December 9, 2010
Last Updated: October 8, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Paraneoplastic Polyneuropathy
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
 Paraneoplastic Syndromes, Nervous System
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Paraneoplastic Syndromes
Neurodegenerative Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 16, 2013