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Flecainide in Treating Patients With Chronic Neuropathic Pain

Primary Purpose

Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
flecainide acetate
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring pain

Eligibility Criteria

19 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • CCOP - Kalamazoo
  • Mayo Clinic Cancer Center
  • CCOP - Sioux Community Cancer Consortium
  • University of Wisconsin Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
June 14, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00002996
Brief Title
Flecainide in Treating Patients With Chronic Neuropathic Pain
Official Title
Flecainide for the Treatment of Chronic Neuropathic Pain: A Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 4, 1998 (Actual)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
flecainide acetate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles F. Von Gunten, MD, PhD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1016
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-3731
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-0001
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18073252
Citation
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.
Results Reference
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Flecainide in Treating Patients With Chronic Neuropathic Pain

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