Scrambler therapy for chemotherapy neuropathy: a randomized phase II pilot trial

• Published in: Supportive care in cancer Vol. 28; no. 3; pp. 1183 - 1197
• Main Authors: Loprinzi, Charles, Le-Rademacher, Jennifer G., Majithia, Neil, McMurray, Ryan P., O’Neill, Carrie R., Bendel, Markus A., Beutler, Andreas, Lachance, Daniel H., Cheville, Andrea, Strick, David M., Black, David F., Tilburt, Jon C., Smith, Thomas J.
• Format: Journal Article
• Language: English
• Published: Berlin/Heidelberg Springer Berlin Heidelberg 01-03-2020; Springer; Springer Nature B.V
• Subjects: Administration, Cutaneous; Adult; Aged; Aged, 80 and over; Antineoplastic Agents - adverse effects; Cancer; Carboplatin; Care and treatment; Chemotherapy; Clinical trials; Communications equipment; Evidence-based medicine; Female; Humans; Ixabepilone; Male; Medical research; Medicine; Medicine & Public Health; Medicine, Experimental; Middle Aged; Neoplasms - drug therapy; Neoplasms - pathology; Nursing; Nursing Research; Oncology; Original Article; Pain; Pain Management - methods; Pain Medicine; Peripheral Nervous System Diseases - chemically induced; Peripheral Nervous System Diseases - pathology; Peripheral Nervous System Diseases - therapy; Pilot Projects; Product development; Quality of Life; Rehabilitation Medicine; Transcutaneous Electric Nerve Stimulation - methods; Transcutaneous electrical nerve stimulation-TENS; Vincristine; TENS; Chemotherapy-induced peripheral neuropathy; Scrambler
• ISSN: 0941-4355; 1433-7339
• DOI: 10.1007/s00520-019-04881-3

Introduction
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.
Methods
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.
Results
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.
Conclusions
The results from this pilot trial were positive, supporting the conduct of further investigations regarding the use of Scrambler Therapy for treating CIPN.