NCT00952848

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	questionnaire administration	Pain Rating Score
OTHER	Sensory Neuropathy Scale instrument	ECOG Common Toxicity Criteria for Sensory Neuropathy scale
OTHER	Quality of Life instrument	Uniscale 0-100 scale global quality of life
DEVICE	MC5-A Scrambler device	Electrical stimulation for 60 minutes

Timeline

• Start date: 2009-06-12
• Primary completion: 2009-10-01
• Completion: 2010-06-01
• First posted: 2009-08-06
• Last updated: 2017-03-29
• Results posted: 2013-03-22