Pain
Conditions
Keywords
pain
Brief summary
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.
Detailed description
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.
Interventions
Sponsors
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Study design
Primary purpose
SUPPORTIVE_CARE
Eligibility
Sex/Gender
ALL
Age
19 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed