Gabapentin For the Control of Hot Flashes in Women With Breast Cancer

Sponsor

Gary Morrow (Other)

Overall Status

Completed

CT.gov ID

NCT00022074

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Gabapentin may be effective for the control of hot flashes. It is not yet known if gabapentin is effective in treating hot flashes.

PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Disorder Breast Cancer Depression Hot Flashes	Drug: gabapentin Procedure: quality-of-life assessment	N/A

Detailed Description

OBJECTIVES:

Compare the effectiveness and side effects of 2 different doses of gabapentin vs placebo for the control of hot flashes and other vasomotor symptoms in women with breast cancer.
Compare quality of life, anxiety, and depression in patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and duration of hot flash symptoms (less than 9 months vs 9 or more months). Patients are randomized to 1 of 3 arms.

Arm I: Patients receive oral placebo 3 times a day.
Arm II: Patients receive oral gabapentin at a low dose 3 times a day.
Arm III: Patients receive oral gabapentin as in arm II for 3 days and then at a high dose 3 times a day.

Treatment on all arms continues for 8 weeks in the absence of unacceptable toxicity. After week 8, patients may receive open-label gabapentin at the discretion of their physicians.

Hot flashes are assessed at baseline and then during weeks 3 and 7 of the study.

Quality of life, anxiety, and depression are assessed at baseline and then at weeks 4 and 8.

Patients are followed at week 12.

PROJECTED ACCRUAL: A total of 408 patients (136 per arm) will be accrued for this study within 18 months.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Control of Vasomotor Symptoms in Women Treated for Breast Cancer

Study Start Date :

Jul 1, 2001

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Diagnosis of breast cancer
Experiencing 2 or more hot flashes per day for at least 1 week
Hormone receptor status:
Not specified

PATIENT CHARACTERISTICS:

Age:

Not specified

Sex:

Female

Menopausal status:

Not specified

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

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

Renal:

Creatinine no greater than 1.25 times ULN

Cardiovascular:

No coronary insufficiency
No myocardial infarction within the past 3 months
No symptomatic cardiac disease
No peripheral vascular disease
No cerebrovascular disease or stroke
No syncope or symptomatic hypotension

Other:

No history of allergic or other adverse reaction to gabapentin
Not pregnant or nursing
Fertile patients must use effective contraception during and for 1 week after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Other

No other concurrent anticonvulsant medication
No concurrent clonidine or venlafaxine

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MBCCOP - Gulf Coast	Mobile	Alabama	United States	36688
2	CCOP - Greater Phoenix	Phoenix	Arizona	United States	85006-2726
3	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona	United States	85259-5404
4	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado	United States	80224
5	MBCCOP - Hawaii	Honolulu	Hawaii	United States	96813
6	CCOP - Central Illinois	Decatur	Illinois	United States	62526
7	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
8	CCOP - Kalamazoo	Kalamazoo	Michigan	United States	49007-3731
9	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota	United States	55416
10	CCOP - Northern New Jersey	Hackensack	New Jersey	United States	07601
11	CCOP - North Shore University Hospital	Manhasset	New York	United States	11030
12	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York	United States	13217
13	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina	United States	27104-4241
14	CCOP - Columbus	Columbus	Ohio	United States	43206
15	CCOP - Dayton	Dayton	Ohio	United States	45429
16	CCOP - Virginia Mason Research Center	Seattle	Washington	United States	98101
17	CCOP - Northwest	Tacoma	Washington	United States	98405-0986
18	CCOP - Marshfield Medical Research and Education Foundation	Marshfield	Wisconsin	United States	54449