Pain Clinical Trial
Official title:
The Efficacy of MC5-A ("Scrambler") Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase II Pilot Trial
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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