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Treatment of Painful Chemotherapy -Induced Peripheral Neuropathy With the MC-5A Pain Therapy Medical Device, a Randomized, Double-Blind, Sham-Controlled Clinical Trial


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Neuropathy, Paraneoplastic

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Trial Information

Treatment of Painful Chemotherapy -Induced Peripheral Neuropathy With the MC-5A Pain Therapy Medical Device, a Randomized, Double-Blind, Sham-Controlled Clinical Trial


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change in Visual Analog Scale pre/post treatment

Outcome Time Frame:

baseline, before/after each treatment, and 3 months after treatment

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

OS10328

NCT ID:

NCT01261780

Start Date:

April 2011

Completion Date:

November 2012

Related Keywords:

  • Neuropathy, Paraneoplastic
  • neuropathy,paraneoplastic
  • paraneoplastic peripheral neuropathy
  • pain
  • hyperalgesia
  • Peripheral Nervous System Diseases
  • Paraneoplastic Polyneuropathy
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Neurotoxicity Syndromes

Name

Location
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792