Flecainide in Treating Patients With Chronic Neuropathic Pain - Full Text View

Sponsor:	Eastern Cooperative Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002996

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: flecainide acetate	Phase II

Study Type:	Interventional
Study Design:	Supportive Care
Official Title:	Flecainide for the Treatment of Chronic Neuropathic Pain: A Phase II Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Flecainide Flecainide acetate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	20
Study Start Date:	February 1998
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002996

Locations

United States, Iowa
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States, 52403-1206
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, South Dakota
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
United States, Wisconsin
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-0001

Sponsors and Collaborators

Eastern Cooperative Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Charles F. Von Gunten, MD, PhD

Robert H. Lurie Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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.

Study ID Numbers:	CDR0000065544, ECOG-1Z95
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00002996 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

pain

Additional relevant MeSH terms:

Therapeutic Uses
Flecainide
Cardiovascular Agents
Anti-Arrhythmia Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2009