MC5-A Scrambler Therapy in Reducing Peripheral Neuropathy Caused by Chemotherapy
Condition: Pain; Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Intervention: scrambler therapy; sham intervention; questionnaire administration
Intervention description: Undergo MC5-A therapy; Undergo sham procedure; Ancillary studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      RATIONALE: Scrambler therapy may help relieve pain from peripheral neuropathy caused by
      chemotherapy.

      PURPOSE: This phase II trial is studying how well MC5-A scrambler therapy works in reducing
      peripheral neuropathy caused by chemotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Received neurotoxic chemotherapy (including taxanes-such as paclitaxel or docetaxel,
             or platinum-based compounds such as carboplatin or cis-platinum or oxaliplatin, or
             vinca alkaloids such as vincristine, vinblastine, or vinorelbine, or proteosome
             inhibitors such as bortezomib); Note: this neurotoxic chemotherapy must have been
             completed more than 3 months prior to when they enter this trial

          -  Pain or symptoms of peripheral neuropathy in the feet of >= 1 month (30 days) duration
             attributed to chemotherapy-induced peripheral neuropathy, for which the patient wants
             intervention

          -  Participants have to relate that numbness, tingling or pain in their toes/feet was at
             least a four out of ten problem during the prior week, on a 0-10 scale where zero was
             no problem and ten was the worst possible problem

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 0, 1, or 2

          -  Life expectancy >= 3 months (90 days)

          -  Ability to complete questionnaire(s) by themselves or with assistance

          -  Provide informed written consent

          -  No change in scheduled analgesic agents for at least one week

        Exclusion Criteria:

          -  Pregnant women

          -  CIPN troubles in the lower extremities more proximal to the mid calf

          -  Patients with implantable drug delivery systems, e.g. Medtronic Synchromed

          -  Patients with heart stents or metal implants such as pacemakers, automatic
             defibrillators, aneurysm clips, vena cava clips and skull plates; (metal implants for
             orthopedic repair, e.g. pins, clips, plates, cages, joint replacements are allowed as
             are central venous access devices)

          -  Patients with a history of myocardial infarction or ischemic heart disease within the
             past six months

          -  Patients with history of epilepsy, brain damage, use of anti-convulsants, symptomatic
             brain metastases

          -  Other identified causes of painful lower extremity paresthesias existing prior to
             chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical
             radiculopathy, pre-existing peripheral neuropathy of another etiology: B12 deficiency,
             Acquired Immunodeficiency Syndrome [AIDS], monoclonal gammopathy, diabetes, heavy
             metal poisoning amyloidosis, syphilis, hyperthyroidism or hypothyroidism, inherited
             neuropathy, etc.)

          -  Skin conditions such as open sores that would prevent proper application of the
             electrodes

          -  Other medical or other condition(s) that in the opinion of the investigators might
             compromise the objectives of the study

          -  Prior treatment with Calmare MC-5A therapy for any reason or knowledge of application
             procedure