The Efficacy of MC5-A ("Scrambler") Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase II Pilot Trial
18 Years
N/A
Both
Chemotherapeutic Agent Toxicity, Neurotoxicity, Pain, Peripheral Neuropathy, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
The Efficacy of MC5-A ("Scrambler") Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase II Pilot Trial
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Change in Pain Score
Outcome Description:
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)
Outcome Time Frame:
15 days
Safety Issue:
No
Principal Investigator
Thomas J. Smith, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Massey Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
CDR0000644516
NCT ID:
NCT00952848
Start Date:
June 2009
Completion Date:
June 2010
Related Keywords:
- Chemotherapeutic Agent Toxicity
- Neurotoxicity
- Pain
- Peripheral Neuropathy
- Unspecified Adult Solid Tumor, Protocol Specific
- pain
- neurotoxicity
- chemotherapeutic agent toxicity
- unspecified adult solid tumor, protocol specific
- peripheral neuropathy
- Peripheral Nervous System Diseases
- Neurotoxicity Syndromes
- Demyelinating Diseases
- Polyneuropathies
- Nerve Compression Syndromes
- Neurologic Manifestations
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