Scrambler therapy for chemotherapy neuropathy: a randomized phase II pilot trial
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Chemotherapy-induced peripheral neuropathy (CIPN) is a prominent clinical problem, with limited effective therapies. Preliminary non-randomized clinical trial data support that Scrambler Therapy is helpful in this situation.
Patients were eligible if they had CIPN symptoms for at least 3 months and CIPN-related tingling or pain at least 4/10 in severity during the week prior to registration. They were randomized to receive Scrambler Therapy versus transcutaneous electrical nerve stimulation (TENS) for 2 weeks. Patient-reported outcomes (PROs) were utilized to measure efficacy and toxicity daily for 2 weeks during therapy and then weekly for 8 additional weeks.
This study accrued 50 patients, 25 to each of the 2 study arms; 46 patients were evaluable. There were twice as many Scrambler-treated patients who had at least a 50% documented improvement during the 2 treatment weeks, from their baseline pain, tingling, and numbness scores, when compared with the TENS-treated patients (from 36 to 56% compared with 16–28% for each symptom). Global Impression of Change scores for “neuropathy symptoms,” pain, and quality of life were similarly improved during the treatment weeks. Patients in the Scrambler group were more likely than those in the TENS group to recommend their treatment to other patients, during both the 2-week treatment period and the 8-week follow-up period (p < 0.0001). Minimal toxicity was observed.
The results from this pilot trial were positive, supporting the conduct of further investigations regarding the use of Scrambler Therapy for treating CIPN.
KeywordsScrambler TENS Chemotherapy-induced peripheral neuropathy
This trial was supported by the Gateway Foundation.
Compliance with ethical standards
The protocol was reviewed and approved by the Mayo Clinic Institutional Review Committee.
Conflict of interest
Both Charles Loprinzi and Thomas Smith had travel-related expenses provided by GEOMC Co. LTD, South Korea, a manufacturer of Scrambler Therapy machines.
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