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

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.

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