Scrambler Therapy for the Reduction of Chemotherapy-Induced Neuropathic Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chemotherapy-Induced Peripheral Neuropathy, Malignant Neoplasm

Intervention / Treatment
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* Device: FitBit
* Other: Gait Assessment Test
* Other: MC5-A Scrambler Therapy
* Other: Quality-of-Life Assessment
* Procedure: Quantitative Sensory Testing
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of cancer and suffer from CIPN for at least 3 months after the end of their last cancer chemotherapy Have average pain intensity of at least 4/10 Be in stable clinical situation (no surgery, radiotherapy, hormone therapy, chemotherapy or other treatment scheduled) in the month following the enrollment) Can give a written informed consent Exclusion Criteria: Pre-existence or history of seizure Pre-existence or history of peripheral neuropathy due to a cause different from neurotoxic chemotherapy (i.e. idiopathic peripheral neuropathy, diabetic neuropathy Pregnancy Present with pacemaker or implantable defibrillators Present or past psychotropic substances and alcohol dependence Inability to understand patients' information and informed consent Skin lesion at the electrode placement site

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (scrambler therapy, sensory test, gait test)<br>Patients undergo scrambler therapy over 30-45 minutes 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. | Device: FitBit<br>* Wear FitBit for gait assessment test<br>Other: Gait Assessment Test<br>* Undergo gait assessment test<br>Other: MC5-A Scrambler Therapy<br>* Undergo scrambler therapy<br>* Other names: Scrambler Therapy;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Procedure: Quantitative Sensory Testing<br>* Undergo quantitative sensory test<br>* Other names: QST;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chemotherapy induced peripheral neuropathic pain (CIPN) score difference | Will be assessed using descriptive statistics such as mean, standard deviation, median, range and confidence intervals. The t-test or Wilcoxon rank sum test and Fisher's exact test may be used to compare variables between patient groups. Correlation between two continuous measures may be assessed using Pearson or Spearman correlation. Other statistical methods may be utilized when appropriate. The Pain inventory is an assessment of pain level on a 11-point numeric rating scales (0=none to 10=worst). | Baseline to the last day of 2-week treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in therapy-induced neuropathy | Will be assessed using therapy induced neuropathy assessment scale. Will be assessed using descriptive statistics such as mean, standard deviation, median, range and confidence intervals. The t-test or Wilcoxon rank sum test and Fisher's exact test may be used to compare variables between patient groups. Correlation between two continuous measures may be assessed using Pearson or Spearman correlation. Other statistical methods may be utilized when appropriate. | Baseline to the last day of 2-week treatment | 
| Change in cancer-related symptoms | Will be assessed using therapy induced neuropathy assessment scale. Will be assessed using descriptive statistics such as mean, standard deviation, median, range and confidence intervals. The t-test or Wilcoxon rank sum test and Fisher's exact test may be used to compare variables between patient groups. Correlation between two continuous measures may be assessed using Pearson or Spearman correlation. Other statistical methods may be utilized when appropriate. | Baseline to the last day of 2-week treatment | 
| Change in physical function and quality of life | Will be assessed using the European Organization of Research and Treatment of Cancer Quality of Life Questionnaire CIPN20 questionnaire. Will be assessed using descriptive statistics such as mean, standard deviation, median, range and confidence intervals. The t-test or Wilcoxon rank sum test and Fisher's exact test may be used to compare variables between patient groups. Correlation between two continuous measures may be assessed using Pearson or Spearman correlation. Other statistical methods may be utilized when appropriate. The Pain inventory is an assessment of pain level on a 11-point numeric rating scales (0=none to 10=worst). | Baseline to the last day of 2-week treatment |