Pain Clinical Trial
Official title:
Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Evaluation of a Sham Procedure and Phase II Trial
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
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
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