Flecainide in Treating Patients With Chronic Neuropathic Pain
NCT ID: NCT00002996
Last Updated: 2023-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
1998-05-04
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of flecainide in treating patients with chronic neuropathic pain from cancer or AIDS.
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Detailed Description
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* 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.
Conditions
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Study Design
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SUPPORTIVE_CARE
Interventions
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flecainide acetate
Eligibility Criteria
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Inclusion Criteria
* 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
19 Years
120 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK
Responsible Party
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Eastern Cooperative Oncology Group
Principal Investigators
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Charles F. Von Gunten, MD, PhD
Role: STUDY_CHAIR
Robert H. Lurie Cancer Center
Locations
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CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Countries
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References
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von Gunten CF, Eappen S, Cleary JF, Taylor SG 4th, Moots P, Regevik N, Cleeland C, Cella D. Flecainide for the treatment of chronic neuropathic pain: a Phase II trial. Palliat Med. 2007 Dec;21(8):667-72. doi: 10.1177/0269216307083031.
Other Identifiers
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E1Z95
Identifier Type: -
Identifier Source: secondary_id
CDR0000065544
Identifier Type: -
Identifier Source: org_study_id
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