NCT04239976

Scrambler Therapy for the Reduction of Chemotherapy-Induced Neuropathic Pain

Effect of Scramble Therapy on Chemotherapy Induced Peripheral Neuropathic Pain: A Prospective, Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well scrambler therapy works in reducing chemotherapy-induced neuropathic pain in patients with cancer. Scrambler therapy is a type of treatment that uses electrodes placed on the skin. Electricity is carried from the electrodes through the skin and blocks the pain.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the efficacy of MC5-A scrambler therapy (scrambler therapy \[ST\]) in reducing chemotherapy-induced painful peripheral neuropathy (CIPPN). II. Evaluate the change in pain score before and after 2 weeks (Monday-Friday) of the final ST treatment. III. Assess for changes in other symptom burden (i.e insomnia, feeling of well-being, depression and anxiety) after 2 weeks (Monday-Friday) ST treatment. SECONDARY OBJECTIVES: I. To evaluate the following with the treatment of ST: Ia. Assess for changes in therapy induced neuropathy assessment scale (TNAS). Ib. Assess for changes in using pain medications. Ic. Assess for changes in daily physical activities/functional status. Id. Assess for changes in quality of life using European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) (chemotherapy induced peripheral neuropathy) chemotherapy-induced neuropathic pain (CIPN) 20 questionnaire. Ie. Assess overall satisfaction with the ST treatment using Global Impression of Change questionnaire. TERTIARY (EXPLORATORY) OBJECTIVE: I. Determine the change in sensation after 2 weeks (Monday-Friday) of the final ST treatment. OUTLINE: Patients undergo scrambler therapy over 30-45 minutes once daily (QD) Monday-Friday for 2 weeks. Patients also undergo a quantitative sensory test and a gait assessment test using a FitBit before receiving scrambler therapy, at the end of the first and second weeks of scrambler therapy, and 1 month after the last day of scrambler therapy. After completion of study, patients are followed up weekly for 3 weeks and at 4 weeks after the last day of scrambler therapy treatment.

Conditions

• Chemotherapy-Induced Peripheral Neuropathy
• Malignant Neoplasm

Interventions

Type	Name	Description
DEVICE	FitBit	Wear FitBit for gait assessment test
OTHER	Gait Assessment Test	Undergo gait assessment test
OTHER	MC5-A Scrambler Therapy	Undergo scrambler therapy
OTHER	Quality-of-Life Assessment	Ancillary studies
PROCEDURE	Quantitative Sensory Testing	Undergo quantitative sensory test
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2019-04-04
• Primary completion: 2022-03-18
• Completion: 2022-03-18
• First posted: 2020-01-27
• Last updated: 2022-03-24

Locations

1 site across 1 country: United States