Electrical Stimulation Pain Therapy in Treating Chronic Pain and Numbness Caused By Chemotherapy in Patients With Cancer

Last updated: August 21, 2013
Sponsor: Virginia Commonwealth University
Overall Status: Completed

Phase

N/A

Condition

Peripheral Neuropathy

Pain

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT01196442
MCC-13098
NCI-2010-01945
  • Ages > 18
  • All Genders

Study Summary

RATIONALE: Electrical stimulation pain therapy may help relieve chronic pain and numbness caused by chemotherapy. PURPOSE: This pilot trial studies electrical stimulation pain therapy in treating chronic pain and numbness caused by chemotherapy in patients with cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • CIPN neuropathy: received, or currently receiving, neurotoxic chemotherapy (includingtaxanes-such as paclitaxel or docetaxel, or platinum-based compounds such ascarboplatin 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 tochemotherapy-induced peripheral neuropathy

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

  • 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 thepatient at least "a little bit" on the CIPN-20

  • Life expectancy >= 3 months

  • ECOG performance status 0, 1, or 2

Exclusion

Exclusion Criteria:

  • Pregnant women, nursing women, women of childbearing potential or their sexualpartners who are unwilling to employ adequate contraception (condoms, diaphragm, birthcontrol 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 electronicnerve stimulation

  • Patients with implantable drug delivery systems, e.g., Medtronic Synchromed

  • Patients with heart stents or metal implants such as pacemakers, automaticdefibrillators, aneurysm clips, vena cava clips and skull plates (metal implants fororthopedic repair, e.g., pins, clips, plates, cages, joint replacements are allowed)

  • Patients with a history of myocardial infarction or ischemic heart disease within thepast six months

  • Patients with history of epilepsy, brain damage, use of anti-convulsants, symptomaticbrain 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-existingperipheral neuropathy of another etiology: B12 deficiency, AIDS, monoclonalgammopathy, diabetes, heavy metal poisoning amyloidosis, syphilis, hyperthyroidism orhypothyroidism, inherited neuropathy)

  • Skin conditions such as open sores that would prevent proper application of theelectrodes

  • Other medical or other condition(s) that in the opinion of the investigators mightcompromise the objectives of the study

Study Design

Total Participants: 39
Study Start date:
September 01, 2010
Estimated Completion Date:
January 31, 2013

Study Description

OBJECTIVES:

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.

Connect with a study center

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

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