Scrambler Therapy for the Reduction of Chemotherapy-Induced Neuropathic Pain
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chemotherapy Induced Peripheral Neuropathy
- Malignant Neoplasm
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 change...
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.
Tracking Information
- NCT #
- NCT04239976
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Salahadin Abdi M.D. Anderson Cancer Center
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