Flecainide in Treating Patients With Chronic Neuropathic Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Flecainide for the Treatment of Chronic Neuropathic Pain: A Phase II Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: flecainide acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: flecainide acetate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain