Anxiety Disorder, Breast Cancer, Depression, Hot Flashes
Conditions
Keywords
stage I breast cancer, stage II breast cancer, stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, anxiety disorder, depression, hot flashes
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.
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.
Interventions
DRUGgabapentin
PROCEDUREquality-of-life assessment
Sponsors
National Cancer Institute (NCI)
Gary Morrow
Study design
Allocation
RANDOMIZED
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 120 Years
Healthy volunteers
No
Inclusion 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 * 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
Countries
United States
Outcome results
None listed