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Flecainide in Treating Patients With Chronic Neuropathic Pain

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Eastern Cooperative Oncology Group Identifier:
First received: November 1, 1999
Last updated: January 26, 2010
Last verified: January 2010

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 2

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

Resource links provided by NLM:

Further study details as provided by Eastern Cooperative Oncology Group:

Estimated Enrollment: 20
Study Start Date: February 1998
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Chronic neuropathic pain with diagnosis of cancer or AIDS



  • Over 18

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • SGOT no greater than 2 times upper limit of normal (ULN)


  • Creatinine no greater than 2 times ULN


  • 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


  • 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


Biologic therapy:

  • Not specified


  • At least 2 weeks since prior chemotherapy that may cause neuropathy

Endocrine therapy:

  • At least 2 weeks since prior corticosteroids


  • Not specified


  • Not specified


  • No tricyclic antidepressant treatment within past 2 weeks
  • No concurrent use of flecainide, mexiletene or any other type I antiarrhythmic drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002996

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)
Study Chair: Charles F. Von Gunten, MD, PhD Robert H. Lurie Cancer Center
  More Information

Responsible Party: Group Chair, Eastern Cooperative Oncology Group Identifier: NCT00002996     History of Changes
Other Study ID Numbers: CDR0000065544
Study First Received: November 1, 1999
Last Updated: January 26, 2010

Keywords provided by Eastern Cooperative Oncology Group:

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on August 18, 2017