Electrical Stimulation Therapy Using the MC5-A Scrambler in Reducing Peripheral Neuropathy Caused by Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00952848|
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : March 22, 2013
Last Update Posted : March 29, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Chemotherapeutic Agent Toxicity Neurotoxicity Pain Peripheral Neuropathy Unspecified Adult Solid Tumor, Protocol Specific||Other: questionnaire administration Other: Sensory Neuropathy Scale instrument Other: Quality of Life instrument Device: MC5-A Scrambler device||Phase 2|
- To determine if MC5-A Scrambler therapy will improve the pain associated with chemotherapy-induced peripheral neuropathy in cancer patients by 20%.
- 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 (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Efficacy of MC5-A ("Scrambler") Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase II Pilot Trial|
|Study Start Date :||June 12, 2009|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||June 2010|
Experimental: MC5-A Scramble instrument
Treatment of chronic neuropathic pain with the MC5-A device
Other: questionnaire administration
Pain Rating ScoreOther: Sensory Neuropathy Scale instrument
ECOG Common Toxicity Criteria for Sensory Neuropathy scaleOther: Quality of Life instrument
Uniscale 0-100 scale global quality of lifeDevice: MC5-A Scrambler device
Electrical stimulation for 60 minutes
- Change in Pain Score [ Time Frame: 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)
- Effect of MC5-A on Pain and Neuropathy [ Time Frame: 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.
- Effect of MC5-A on Morphine Oral Equivalent Doses Used Before and After MC5-A Therapy [ Time Frame: 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
- Toxicity of MC5-A Therapy on Global Quality of Life Using the Uniscale Instrument [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00952848
|Principal Investigator:||Thomas J. Smith, MD||Massey Cancer Center|