MC5-A Scrambler Therapy in Reducing Peripheral Neuropathy Caused by Chemotherapy

Study Overview
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Brief Summary
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RATIONALE: Scrambler therapy may help relieve pain from peripheral neuropathy caused by chemotherapy. PURPOSE: This phase II trial is studying how well MC5-A scrambler therapy works in reducing peripheral neuropathy caused by chemotherapy

Detailed Description
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PRIMARY OBJECTIVES: I. To explore the feasibility of studying scrambler therapy versus a sham procedure for the alleviation of lower extremity chemotherapy induced peripheral neuropathy (CIPN). SECONDARY OBJECTIVES: I. To obtain prospective pilot experience with recommended scrambler therapy, with regards to treatment efficacy to determine effect size estimates, patient related outcome measurement tools that we use in this trial, tolerability, and analgesic use. OUTLINE: Patients undergo a sham procedure on the back or scrambler therapy on both lower extremities for up to 30 minutes with the Calmare MC5-A device and cutaneous electrode patches applied above and below the area of pain on days 1 and 2. Patients continue scrambler therapy for 10 days in the absence of unacceptable toxicity.

Official Title
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Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Evaluation of a Sham Procedure and Phase II Trial

Conditions
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Pain, Peripheral Neuropathy

Intervention / Treatment
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* Other: scrambler therapy
* Procedure: sham intervention
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Received neurotoxic chemotherapy (including taxanes-such as paclitaxel or docetaxel, or platinum-based compounds such as carboplatin or cis-platinum or oxaliplatin, or vinca alkaloids such as vincristine, vinblastine, or vinorelbine, or proteosome inhibitors such as bortezomib); Note: this neurotoxic chemotherapy must have been completed more than 3 months prior to when they enter this trial Pain or symptoms of peripheral neuropathy in the feet of >= 1 month (30 days) duration attributed to chemotherapy-induced peripheral neuropathy, for which the patient wants intervention Participants have to relate that numbness, tingling or pain in their toes/feet was at least a four out of ten problem during the prior week, on a 0-10 scale where zero was no problem and ten was the worst possible problem Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0, 1, or 2 Life expectancy >= 3 months (90 days) Ability to complete questionnaire(s) by themselves or with assistance Provide informed written consent No change in scheduled analgesic agents for at least one week Exclusion Criteria: Pregnant women CIPN troubles in the lower extremities more proximal to the mid calf Patients with implantable drug delivery systems, e.g. Medtronic Synchromed Patients with heart stents or metal implants such as pacemakers, automatic defibrillators, aneurysm clips, vena cava clips and skull plates; (metal implants for orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as are central venous access devices) Patients with a history of myocardial infarction or ischemic heart disease within the past six months Patients with history of epilepsy, brain damage, use of anti-convulsants, symptomatic brain metastases Other identified causes of painful lower extremity paresthesias existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology: B12 deficiency, Acquired Immunodeficiency Syndrome [AIDS], monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited neuropathy, etc.) Skin conditions such as open sores that would prevent proper application of the electrodes Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study Prior treatment with Calmare MC-5A therapy for any reason or knowledge of application procedure

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care<br>See Detailed Description | Other: scrambler therapy<br>* Undergo MC5-A therapy<br>* Other names: transcutaneous electromanipulation by nervous patterns scrambler therapy;Procedure: sham intervention<br>* Undergo sham procedure<br>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 |
| --- | --- | --- |
| Percentage of Patients Who Have at Least a 50% Reduction (i.e., Success) in at Least 1 of the First 12 Chemotherapy Induced Peripheral Neuropathy (CIPN) Measurement Questions in the Pre/Post Therapy Questionnaire | CIPN measurement items score range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now, at its worst over the past 24 hours, and on average over the past 24 hours. | On days 1 and 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Change of CIPN Symptoms Between Sham Procedure and Scrambler Therapy as Measured by Each Individual Question | The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H). Averaged change between day 1 and day 2 across 10 patients was calculated. | On days 1 and 2 | 
| Percentage of Reduction at Days 10 From Day 1 in Each of the 12 CIPN Measurement Questions in the Daily Therapy Questionnaire | The 12 CIPN symptoms individual question range: 0 (none) to 10 (as bad as can be). The questions assessed the intensity of numbness, tingling, or pain in toes or feet that patients have had right now (RN), at its worst over the past 24 hours (WP24H), and on average over the past 24 hours (AvgP24H). | Day 1 and Day 10 | 
| Percentage of Reduction at Weeks 10 From Week 1 in CIPN Symptoms as Measured by the North Central Cancer Treatment Group (NCCTG) Peripheral Neuropathy Question | The NCCTG peripheral neuropathy question range: 0 (No numbness or tingling or pain in fingers and/or toes) to 10 (Numbness, tingling or pain in fingers and/pr toes as bad as you can imagine). The question assessed the intensity of numbness, tingling or pain in toes or feet in the past week. | Week 1 and Week 10 | 
| Percent Change From Day 1 at Week 10 in CIPN Symptom Bother as Measured by 8 CIPN Symptom Questions | The intensity of symptom was measured in a likert scale: none at all (0), a little bit (1), quite a bit (2) and very much (3). Percent change from day 1 at week 10 for each patient was calculated and average of percentage was reported. | Day 1 and Week 10 | 
| Toxicity (Other Than CIPN) Profile Associated With Scrambler Therapy as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 4.0 | CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death. | Day 1 to Day 10 | 
| Analgesic Use Over Time |  | On days 1-11 and for 10 weeks after therapy |