Scrambler therapy for chemotherapy neuropathy

a randomized phase II pilot trial

Charles Lawrence Loprinzi, Jennifer Le-Rademacher, Neil Majithia, Ryan P. McMurray, Carrie R. O’Neill, Markus A. Bendel, Andreas S Beutler, Daniel H. Lachance, Andrea L Cheville, David M. Strick, David Black, Jon C Tilburt, Thomas J. Smith

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
JournalSupportive Care in Cancer
DOIs
StatePublished - Jan 1 2019

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Drug Therapy
Peripheral Nervous System Diseases
Transcutaneous Electric Nerve Stimulation
Therapeutics
Pain
Hypesthesia
Quality of Life

Keywords

  • Chemotherapy-induced peripheral neuropathy
  • Scrambler
  • TENS

ASJC Scopus subject areas

  • Oncology

Cite this

Scrambler therapy for chemotherapy neuropathy : a randomized phase II pilot trial. / Loprinzi, Charles Lawrence; Le-Rademacher, Jennifer; Majithia, Neil; McMurray, Ryan P.; O’Neill, Carrie R.; Bendel, Markus A.; Beutler, Andreas S; Lachance, Daniel H.; Cheville, Andrea L; Strick, David M.; Black, David; Tilburt, Jon C; Smith, Thomas J.

In: Supportive Care in Cancer, 01.01.2019.

Research output: Contribution to journalArticle

Loprinzi, Charles Lawrence ; Le-Rademacher, Jennifer ; Majithia, Neil ; McMurray, Ryan P. ; O’Neill, Carrie R. ; Bendel, Markus A. ; Beutler, Andreas S ; Lachance, Daniel H. ; Cheville, Andrea L ; Strick, David M. ; Black, David ; Tilburt, Jon C ; Smith, Thomas J. / Scrambler therapy for chemotherapy neuropathy : a randomized phase II pilot trial. In: Supportive Care in Cancer. 2019.
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abstract = "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.",
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T2 - a randomized phase II pilot trial

AU - Loprinzi, Charles Lawrence

AU - Le-Rademacher, Jennifer

AU - Majithia, Neil

AU - McMurray, Ryan P.

AU - O’Neill, Carrie R.

AU - Bendel, Markus A.

AU - Beutler, Andreas S

AU - Lachance, Daniel H.

AU - Cheville, Andrea L

AU - Strick, David M.

AU - Black, David

AU - Tilburt, Jon C

AU - Smith, Thomas J.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

AB - 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.

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