Phase
Condition
Peripheral Neuropathy
Pain
Neurologic Disorders
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
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
Study Description
Connect with a study center
Virginia Commonwealth University
Richmond, Virginia 23298
United StatesSite Not Available

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