Flecainide for the Treatment of Chronic Neuropathic Pain: A Phase II Trial
flecainide acetate
Neurologic Manifestations+1
+ Signs and Symptoms
+ Pathological Conditions, Signs and Symptoms
Supportive Care Study
Summary
Study start date: May 4, 1998
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 19 to 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 6 locations
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, United StatesOpen CCOP - Cedar Rapids Oncology Project in Google MapsCCOP - Iowa Oncology Research Association
Des Moines, United StatesCCOP - Kalamazoo
Kalamazoo, United StatesMayo Clinic Cancer Center
Rochester, United States