Status:
COMPLETED
Electrical Stimulation Therapy Using the MC5-A Scrambler in Reducing Peripheral Neuropathy Caused by Chemotherapy
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chemotherapeutic Agent Toxicity
Neurotoxicity
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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 ...
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 th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 12 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00952848
Start Date
June 12 2009
End Date
June 1 2010
Last Update
March 29 2017
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