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

Phase 2

Completed

• Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Chemotherapeutic Agent Toxicity; Pain; Neurotoxicity; Peripheral Neuropathy
• Interventions: Other: questionnaire administration; Other: Sensory Neuropathy Scale instrument; Other: Quality of Life instrument; Device: MC5-A Scrambler device

• Registration Number: NCT00952848
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study Start: 2009-06-12
• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Primary Completion: 2009-10
• Study Completion: 2010-06
• Results First Submitted: 2012-11-30
• Results First Submitted QC: 2013-02-15
• Results First Posted: 2013-03-22
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MC5-A Scramble instrument	questionnaire administration	Treatment of chronic neuropathic pain with the MC5-A device
MC5-A Scramble instrument	Sensory Neuropathy Scale instrument	Treatment of chronic neuropathic pain with the MC5-A device
MC5-A Scramble instrument	Quality of Life instrument	Treatment of chronic neuropathic pain with the MC5-A device
MC5-A Scramble instrument	MC5-A Scrambler device	Treatment of chronic neuropathic pain with the MC5-A device

Primary Outcome Measures

Name	Time	Method
Change in Pain Score	15 days	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)

Secondary Outcome Measures

Name	Time	Method
Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy	2 weeks	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
Effect of MC5-A on Pain and Neuropathy	2 weeks	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.
Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument	2 weeks	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.