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Effect of Scramble Therapy on Chemotherapy Induced Peripheral Neuropathic Pain: A Prospective, Pilot Study
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
M D Anderson Cancer Center
Houston, Texas, United States
Start Date
April 4, 2019
Primary Completion Date
March 18, 2022
Completion Date
March 18, 2022
Last Updated
March 24, 2022
16
ACTUAL participants
FitBit
DEVICE
Gait Assessment Test
OTHER
MC5-A Scrambler Therapy
OTHER
Quality-of-Life Assessment
OTHER
Quantitative Sensory Testing
PROCEDURE
Questionnaire Administration
OTHER
Lead Sponsor
M.D. Anderson Cancer Center
Collaborators
NCT00026884
NCT04585750
Data Source & Attribution
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