Electrical Stimulation Therapy Using the MC5-A Scrambler in Reducing Peripheral Neuropathy Caused by Chemotherapy
Condition: Chemotherapeutic Agent Toxicity; Neurotoxicity; Pain; Peripheral Neuropathy; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Peripheral Nervous System Diseases; Neurotoxicity Syndromes
Intervention: questionnaire administration; Sensory Neuropathy Scale instrument; Quality of Life instrument; MC5-A Scrambler device
Intervention description: Pain Rating Score; ECOG Common Toxicity Criteria for Sensory Neuropathy scale; Uniscale 0-100 scale global quality of life; Electrical stimulation for 60 minutes
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: pain; neurotoxicity; chemotherapeutic agent toxicity; unspecified adult solid tumor, protocol specific; peripheral neuropathy

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.
    

Eligibility 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