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

Gary Morrow

Status

Completed

Conditions

Breast Cancer

Anxiety Disorder

Hot Flashes

Depression

Treatments

Drug: gabapentin

Procedure: quality-of-life assessment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00022074

NCI-P01-0183

URCC-U2101

CDR0000068780

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

Under 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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