Flecainide in Treating Patients With Chronic Neuropathic Pain

June 14, 2023 updated by: Eastern Cooperative Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 1998

Primary Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimated)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000065544
  • E1Z95

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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