Electrical Stimulation Pain Therapy in Treating Chronic Pain and Numbness Caused By Chemotherapy in Patients With Cancer
NCT ID: NCT01196442
Last Updated: 2013-08-23
Study Results
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View full resultsBasic Information
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COMPLETED
NA
39 participants
INTERVENTIONAL
2010-09-30
2013-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I electric stimulation pain therapy
Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.
electrical stimulation pain therapy
Electrical stimulation pain therapy for 45 minutes on Day 1, then 30 minutes Days 2-10
questionnaire administration
Brief Pain Inventory questionnaire administration at baseline, weekly, then monthly for 3 months
Interventions
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electrical stimulation pain therapy
Electrical stimulation pain therapy for 45 minutes on Day 1, then 30 minutes Days 2-10
questionnaire administration
Brief Pain Inventory questionnaire administration at baseline, weekly, then monthly for 3 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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, 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 the patient at least "a little bit" on the CIPN-20
* Life expectancy \>= 3 months
* ECOG performance status 0, 1, or 2
Exclusion Criteria
* 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 electrodes
* Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study
18 Years
ALL
No
Sponsors
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Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Craig Swainey, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Related Links
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VCU Massey Cancer Center
Other Identifiers
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NCI-2010-01945
Identifier Type: REGISTRY
Identifier Source: secondary_id
MCC-13098
Identifier Type: -
Identifier Source: org_study_id