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An Expanded Trial of MC5-A Calmare Therapy in the Treatment of Cancer Pain Syndromes and Chronic Chemotherapy-Induced Peripheral Neuropathy Including Pain and Numbness

18 Years
Not Enrolling
Cancer-related Problem/Condition, Neurotoxicity, Pain, Peripheral Neuropathy

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Trial Information

An Expanded Trial of MC5-A Calmare Therapy in the Treatment of Cancer Pain Syndromes and Chronic Chemotherapy-Induced Peripheral Neuropathy Including Pain and Numbness


I. To evaluate the effect of MC5-A on pain symptoms both immediately and over time.

II. To evaluate the effect of Calmare therapy on other non-pain symptoms. III. To evaluate
the effect of MC5-A on daily opioid and other pain medication use.

OUTLINE: Patients undergo electric stimulation pain therapy comprising MC5-A Calmare
therapy over 30 minutes once daily for 10 days. After completion of study treatment,
patients are followed up for 3 months.

Inclusion Criteria:

- CIPN neuropathy: received, or currently receiving, 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)

- Pain or symptoms of peripheral neuropathy of >= 1 months duration attributed to
chemotherapy-induced peripheral neuropathy

- OR pain of the other types including chemotherapy-induced peripheral neuropathy,
numbness predominant; post mastectomy pain; post surgical pain; post herpetic
neuropathy; post radiation pain; other (vertebral compression, fracture,

- The pain must have been stable for at least 2 weeks

- An average daily pain rating of >= 5 out of 10, using the pain numerical rating scale
(NRS: 0 is no pain and 10 is worst pain possible); or numbness that bothers the
patient at least "a little bit" on the CIPN-20

- Life expectancy >= 3 months

- ECOG performance status 0, 1, or 2

Exclusion Criteria:

- Pregnant women, nursing women, women of childbearing potential or their sexual
partners who are unwilling to employ adequate contraception (condoms, diaphragm,
birth control pills, injections, intrauterine device [IUD], surgical sterilization,
subcutaneous implants, abstinence, etc.)

- Use of an investigational agent for pain control concurrently or =< 30 days

- History of an allergic reaction or previous intolerance to transcutaneous electronic
nerve stimulation

- 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)

- 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

- Prior celiac plexus block, or other neurolytic pain control treatment within 4 weeks

- Other identified causes of painful paresthesias existing prior to chemotherapy (e.g.,
radiation or malignant plexopathy, lumbar or cervical radiculopathy, pre-existing
peripheral neuropathy of another etiology: B12 deficiency, AIDS, monoclonal
gammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism or
hypothyroidism, inherited neuropathy)

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Change in Pain Score From Day 1 to Day 10

Outcome Description:

Change in Brief Pain Inventory (Now)Scale 1 (none) to 5 (complete interference)

Outcome Time Frame:

From day 1 to day 10

Safety Issue:


Principal Investigator

Craig Swainey, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University


United States: Institutional Review Board

Study ID:




Start Date:

September 2010

Completion Date:

January 2013

Related Keywords:

  • Cancer-Related Problem/Condition
  • Neurotoxicity
  • Pain
  • Peripheral Neuropathy
  • Peripheral Nervous System Diseases
  • Neurotoxicity Syndromes



Virginia Commonwealth UniversityRichmond, Virginia