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Clinical Trials/NCT00952848
NCT00952848CompletedPhase 2

The Efficacy of MC5-A ("Scrambler") Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase II Pilot Trial

Virginia Commonwealth University0 sites18 target enrollmentStarted: June 12, 2009Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
18
Primary Endpoint
Change in Pain Score
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

RATIONALE: Electronic stimulation using a MC5-A Scrambler may help relieve pain in patients who develop peripheral neuropathy while undergoing chemotherapy treatments for cancer.

PURPOSE: This phase II trial is studying how well MC5-A Scrambler therapy works in reducing peripheral neuropathy caused by chemotherapy.

Detailed Description

OBJECTIVES:

Primary

  • To determine if MC5-A Scrambler therapy will improve the pain associated with chemotherapy-induced peripheral neuropathy in cancer patients by 20%.

Secondary

  • To evaluate the effect of MC5-A therapy on specific pain and neuropathy scales.
  • To evaluate the effect of MC5-A therapy on overall quality of life.
  • To evaluate the effect of MC5-A therapy on other pain drugs used.
  • To evaluate the toxicities of MC5-A therapy.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 120 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in Pain Score

Time Frame: 15 days

Change in Neumeric Rating Score for Pain as measured by a Numeric Pain Rating scale between day 0 to day 15. Scale is 0 (none) to 10 (severe)

Secondary Outcomes

  • Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy(2 weeks)
  • Effect of MC5-A on Pain and Neuropathy(2 weeks)
  • Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument(2 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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