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

Phase 2
18 Years
Open (Enrolling)
Pain, Peripheral Neuropathy

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Trial Information

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


I. To explore the feasibility of studying scrambler therapy versus a sham procedure for the
alleviation of lower extremity chemotherapy induced peripheral neuropathy (CIPN).


I. To obtain prospective pilot experience with recommended scrambler therapy, with regards
to treatment efficacy to determine effect size estimates, patient related outcome
measurement tools that we use in this trial, tolerability, and analgesic use.

OUTLINE: Patients undergo a sham procedure on the back or scrambler therapy on both lower
extremities for up to 30 minutes with the Calmare MC5-A device and cutaneous electrode
patches applied above and below the area of pain on days 1 and 2. Patients continue
scrambler therapy for 10 days in the absence of unacceptable toxicity.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

Percentage of patients who have at least a 50% reduction (i.e., success) in at least 1 of the first 12 CIPN measurement questions in the pre/post therapy questionnaire

Outcome Time Frame:

On days 1 and 2

Safety Issue:


Principal Investigator

Charles Loprinzi, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

February 2011

Completion Date:

Related Keywords:

  • Pain
  • Peripheral Neuropathy
  • Peripheral Nervous System Diseases
  • Demyelinating Diseases
  • Polyneuropathies
  • Nerve Compression Syndromes
  • Neurologic Manifestations
  • Neurotoxicity Syndromes



Mayo ClinicRochester, Minnesota  55905