Electrical Stimulation Therapy Using the MC5-A Scrambler in Reducing Peripheral Neuropathy Caused by Chemotherapy

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Electronic stimulation using a MC5-A Scrambler may help relieve pain in patients who develop peripheral neuropathy while undergoing chemotherapy treatments for cancer. PURPOSE: This phase II trial is studying how well MC5-A Scrambler therapy works in reducing peripheral neuropathy caused by chemotherapy.

Detailed Description
-----------------
OBJECTIVES: Primary To determine if MC5-A Scrambler therapy will improve the pain associated with chemotherapy-induced peripheral neuropathy in cancer patients by 20%. Secondary To evaluate the effect of MC5-A therapy on specific pain and neuropathy scales. To evaluate the effect of MC5-A therapy on overall quality of life. To evaluate the effect of MC5-A therapy on other pain drugs used. To evaluate the toxicities of MC5-A therapy. OUTLINE: Patients undergo gel electrode application on the skin in the most pain-free of the pain-affected area. Patients undergo treatment with the MC5-A Scrambler machine over 60 minutes once daily on days 1-10. On day 1, the treatment intensity is increased every 10 minutes to the maximum intensity individually bearable by the patient without any input of pain or discomfort. The patient should feel the disappearance of the pain during treatment as a sign that the proper nerve pathway(s) has (have) been correctly identified. Subsequent treatments begin at the highest intensity tolerated at the previous treatment. Patients with no improvement after 3 treatments discontinue treatment. Patients complete questionnaires about symptoms, pain, and quality of life periodically. After completion of study treatment, patients are followed up at 2 and 4 weeks, monthly for 3 months, and at 6 months.

Official Title
-----------------
The Efficacy of MC5-A (Scrambler) Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase II Pilot Trial

Conditions
-----------------
Chemotherapeutic Agent Toxicity, Neurotoxicity, Pain, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Other: questionnaire administration
* Other: Sensory Neuropathy Scale instrument
* Other: Quality of Life instrument
* Device: MC5-A Scrambler device


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Chemotherapy-induced peripheral neuropathy (CIPN) meeting the following criteria: More than 4 weeks since prior neurotoxic chemotherapy including taxanes (e.g., paclitaxel or docetaxel), platinum-based compounds (e.g., carboplatin, cis-platinum, oxaliplatin), vinca-alkaloids (e.g., vincristine, vinblastine, or vinorelbine), or proteosome inhibitors (e.g., bortezomib) Pain or symptoms of peripheral neuropathy for ≥ 1 month attributed to CIPN Pain stable for ≥ 2 weeks Average daily pain rating of ≥ 5 out of 10 using the pain numerical rating scale (0 is no pain and 10 is worst pain possible) No symptomatic brain metastases PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy ≥ 3 months Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of an allergic reaction or intolerance to transcutaneous electronic nerve stimulation No pacemaker or implantable drug-delivery system (e.g., Medtronic Synchromed) No heart stent or vena cava clips No history of epilepsy or brain damage No other identified causes of painful paresthesias existing before chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology [e.g., B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism, hypothyroidism, inherited neuropathy, etc.]) No skin conditions (e.g., open sores) that would prevent proper application of the electrodes No other medical or other conditions that, in the opinion of the investigators, might compromise the objectives of the study PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 30 days since prior and no concurrent investigational agents for pain control More than 4 weeks since prior and no concurrent celiac plexus block or other neurolytic pain control treatment No prior or concurrent anti-convulsants No concurrent neurotoxic or potentially neurotoxic chemotherapy Concurrent pain treatments allowed provided the following criteria are met: Pain is not satisfactorily controlled Dose of the other medication has been stable for ≥ 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MC5-A Scramble instrument<br>Treatment of chronic neuropathic pain with the MC5-A device | Other: questionnaire administration<br>* Pain Rating Score<br>Other: Sensory Neuropathy Scale instrument<br>* ECOG Common Toxicity Criteria for Sensory Neuropathy scale<br>Other: Quality of Life instrument<br>* Uniscale 0-100 scale global quality of life<br>Device: MC5-A Scrambler device<br>* Electrical stimulation for 60 minutes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Score | Change in Neumeric Rating Score for Pain as measured by a Numeric Pain Rating scale between day 0 to day 15. Scale is 0 (none) to 10 (severe) | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of MC5-A on Pain and Neuropathy | Change on pain and neuropathy as measured by the Eastern Cooperative Oncology Group (ECOG) Common Toxicity Criteria for Sensory Neuropathy scale,0=none to 4=paralysis; the World Health Organization (WHO) Classification Scale, 0=none to 4=paralysis; and the Brief Pain Inventory-Short Form, 0=none to 4=most intense pain imaginable. Scores will be averaged. | 2 weeks | 
| Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy | The change in overal equivalent doses (all narcotic doses will be converted to morphine oral equivalent doses ie as mg/24hours. (All opiates taken will be recorded for the full 24 hours preceding the visit or phone call. All opiates will be converted to the pnmorphine equivalent using the Morphine oral dose equivalents (MOED). The total MOEDs taken during the 24 hours will be the sum of all opiates taken) used before intervention | 2 weeks | 
| Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument | Change on global quality of life. The global quality of life will improve as measured by the Uniscale Linear Analog Scale Assessment (LASA) quality of life scale 0=as bad as it can be to 10=as good as it can be. Scores will be averaged. | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, neurotoxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific, peripheral neuropathy