Clinical trial NCT00002996: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: pain
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cedar Rapids
country: United States
facility: CCOP - Cedar Rapids Oncology Project
state: Iowa
city: Des Moines
country: United States
facility: CCOP - Iowa Oncology Research Association
state: Iowa
city: Kalamazoo
country: United States
facility: CCOP - Kalamazoo
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Cancer Center
state: Minnesota
city: Sioux Falls
country: United States
facility: CCOP - Sioux Community Cancer Consortium
state: South Dakota
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Charles F. Von Gunten, MD, PhD
role: STUDY_CHAIR
References:
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.