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Home > "F" Clinical Trials Conditions > Flecainide in Treating Patients With Chronic Neuropathic Pain  Flecainide in Treating Patients With Chronic Neuropathic Pain
Flecainide in Treating Patients With Chronic Neuropathic Pain
For Condition: Pain
Status: No longer recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Flecainide therapy may help patients with neuropathic pain live more comfortably. PURPOSE: Phase II trial to study the effectiveness of flecainide in treating patients with chronic neuropathic pain from cancer or AIDS.
Details: OBJECTIVES: - Investigate the effectiveness of flecainide in the management of neuropathic pain. OUTLINE: Patients are given a brief pain inventory (BPI) form to assess their pain upon enrollment in the study. Following a 7 day stabilization period, flecainide is administered. One capsule of flecainide is given twice a day on days 8-10, two capsules are given twice a day on days 11-14 and three capsules are given twice a day on days 15-21. BPI forms are completed on days 8, 15 and 22 to assess neuropathic pain. PROJECTED ACCRUAL: A total of 7-20 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 19 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Chronic neuropathic pain with diagnosis of cancer or AIDS PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - SGOT no greater than 2 times upper limit of normal (ULN) Renal: - Creatinine no greater than 2 times ULN Cardiovascular: - No clinical history of infarction or angina - No advanced heart failure - No sick sinus syndrome, intraventricular conduction disease, second or third degree AV block or arrhythmias requiring treatment (exception may be granted by cardiac consult) - No focal wall motion abnormalities - Ejection fraction at least 40% - Systolic blood pressure at least 90 mm Hg Other: - Must be able to take oral medication - No known allergy or adverse reaction to flecainide, mexilitene or any other type I antiarrhythmic drug - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 2 weeks since prior chemotherapy that may cause neuropathy Endocrine therapy: - At least 2 weeks since prior corticosteroids Radiotherapy: - Not specified Surgery: - Not specified Other: - No tricyclic antidepressant treatment within past 2 weeks - No concurrent use of flecainide, mexiletene or any other type I antiarrhythmic drug
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesVon Gunten, Study Chair, Robert H. Lurie Cancer Center
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-0001
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Additional Information:
Study ID Numbers: CDR0000065544; ECOG-1Z95
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002996
Other Pain Studies:
1. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy
2. Studies of Dextromethorphan and Topiramate to Treat Oral and Facial Pain
3. Influence of Genetics in Pain Sensitivity
4. Radiofrequency Ablation in Relieving Pain in Patients With Bones Metastases
5. Acupuncture and Acupressure in Treating Patients With Moderate or Severe Pain Related to Stage III or Stage IV Pancreatic Cancer
Related Studies:
Other Pain Clinical Trials
Other Wisconsin Clinical Trials
Other Madison Clinical Trials
Flecainide in Treating Patients With Chronic Neuropathic Pain
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