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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00952848
First received: August 4, 2009
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Change in Pain Score [ Time Frame: 15 days ] [ Designated as safety issue: No ]

    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:
  • Effect of MC5-A on Pain and Neuropathy [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 18
Study Start Date: June 2009
Study Completion Date: June 2010
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MC5-A Scramble instrument
Treatment of chronic neuropathic pain with the MC5-A device
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Chemotherapy-induced peripheral neuropathy (CIPN) meeting the following criteria:

    • More than 4 weeks since prior neurotoxic chemotherapy including taxanes (e.g., paclitaxel or docetaxel), platinum-based compounds (e.g., carboplatin, cis-platinum, oxaliplatin), vinca-alkaloids (e.g., vincristine, vinblastine, or vinorelbine), or proteosome inhibitors (e.g., bortezomib)
    • Pain or symptoms of peripheral neuropathy for ≥ 1 month attributed to CIPN
    • Pain stable for ≥ 2 weeks
    • Average daily pain rating of ≥ 5 out of 10 using the pain numerical rating scale (0 is no pain and 10 is worst pain possible)
  • No symptomatic brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 3 months
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of an allergic reaction or intolerance to transcutaneous electronic nerve stimulation
  • No pacemaker or implantable drug-delivery system (e.g., Medtronic Synchromed)
  • No heart stent or vena cava clips
  • No history of epilepsy or brain damage
  • No other identified causes of painful paresthesias existing before chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing peripheral neuropathy of another etiology [e.g., B12 deficiency, AIDS, monoclonal gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism, hypothyroidism, inherited neuropathy, etc.])
  • No skin conditions (e.g., open sores) that would prevent proper application of the electrodes
  • No other medical or other conditions that, in the opinion of the investigators, might compromise the objectives of the study

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 30 days since prior and no concurrent investigational agents for pain control
  • More than 4 weeks since prior and no concurrent celiac plexus block or other neurolytic pain control treatment
  • No prior or concurrent anti-convulsants
  • No concurrent neurotoxic or potentially neurotoxic chemotherapy
  • Concurrent pain treatments allowed provided the following criteria are met:

    • Pain is not satisfactorily controlled
    • Dose of the other medication has been stable for ≥ 4 weeks
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00952848

Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Thomas J. Smith, MD Massey Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00952848     History of Changes
Other Study ID Numbers: CDR0000644516, MCV-MCC-12110
Study First Received: August 4, 2009
Results First Received: November 30, 2012
Last Updated: April 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
pain
neurotoxicity
chemotherapeutic agent toxicity
unspecified adult solid tumor, protocol specific
peripheral neuropathy

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Chemically-Induced Disorders
Nervous System Diseases
Neuromuscular Diseases
Poisoning

ClinicalTrials.gov processed this record on October 29, 2014