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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
18
Pain Rating Score
ECOG Common Toxicity Criteria for Sensory Neuropathy scale
Uniscale 0-100 scale global quality of life
Electrical stimulation for 60 minutes
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)
Time frame: 15 days
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.
Time frame: 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
Time frame: 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.
Time frame: 2 weeks
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