Fall 2015 – Clinical Trial in Progress:
Scrambler Therapy in Treating Pain and Peripheral Neuropathy in Patients Previously Treated with Chemotherapy
Mayo Clinic Clinical trial patient Karen Safranek report:
The Mayo Clinic Cancer Center reported in its quarterly publication, Forefront–Translating Research into Clinical Advances, (page 5, beginning on bottom left and continuing to right column):
“In addition, the group continues to evaluate promising therapies to alleviate CIPN. This work, using randomized, placebo-controlled studies, has helped better define agents that do not appear to be helpful and newly discovered
agents that look more promising. While no markedly effective therapies have been identified for treatment of established CIPN, the group continues to explore new and promising agents.
This work has included the study of the value of using an electrocutaneous nerve stimulation device, called MC-5A Calmare®, also known as “scrambler therapy.” The MC5-A Calmare® device provides cutaneous electrostimulation by simulating nerve action potentials and directly stimulating peripheral nerves.
The MC5-A Calmare® device is not thought to act just by inhibiting pain transmission, but instead by substituting “pain” information with “non-pain” information. It is thought that it does this by mixing another signal into the pain signal transmission, which replaces the original pain information, thus the term, “scrambler therapy.”
Based on pilot data from another group of investigators, supporting that this therapy was useful in patients with chemotherapy neuropathy, Mayo is evaluating this treatment in patients with chemotherapy neuropathy and other pain states. Initial data from Mayo support that this treatment looks promising and deserves to be evaluated in a placebo-controlled, randomized study.”
Mayo Clinic oncologist and professor Dr. Charles L. Loprinzi reports to Reuters News Service about his clinical findings using Calmare scrambler treatment http://news.yahoo.com/video/scrambling-away-pain-cancer-patients-160603523.html
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
|Official Title:||Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Evaluation of a Sham Procedure and Phase II Trial|