NCT01290224

MC5-A Scrambler Therapy in Reducing Peripheral Neuropathy Caused by Chemotherapy

Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Evaluation of a Sham Procedure and Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy. PURPOSE: This phase II trial is studying how well MC5-A scrambler therapy works in reducing peripheral neuropathy caused by chemotherapy

Detailed description

PRIMARY OBJECTIVES: I. To explore the feasibility of studying scrambler therapy versus a sham procedure for the alleviation of lower extremity chemotherapy induced peripheral neuropathy (CIPN). SECONDARY OBJECTIVES: I. To obtain prospective pilot experience with recommended scrambler therapy, with regards to treatment efficacy to determine effect size estimates, patient related outcome measurement tools that we use in this trial, tolerability, and analgesic use. OUTLINE: Patients undergo a sham procedure on the back or scrambler therapy on both lower extremities for up to 30 minutes with the Calmare MC5-A device and cutaneous electrode patches applied above and below the area of pain on days 1 and 2. Patients continue scrambler therapy for 10 days in the absence of unacceptable toxicity.

Conditions

• Pain
• Peripheral Neuropathy

Interventions

Type	Name	Description
OTHER	scrambler therapy	Undergo MC5-A therapy
PROCEDURE	sham intervention	Undergo sham procedure
OTHER	questionnaire administration	Ancillary studies

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-05-01
• Completion: 2011-06-01
• First posted: 2011-02-04
• Last updated: 2014-03-05
• Results posted: 2014-03-05

Locations

1 site across 1 country: United States