Scrambler Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy: An Evaluation of a Sham Procedure and Phase II Trial

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