A Phase III Randomized, Trial of Gabapentin Alone or in Conjunction With an Antidepressant in the Management of Hot Flashes in Women Who Have Inadequate Control With an Antidepressant Alone
A Phase III Randomized, Trial of Gabapentin Alone or in Conjunction With an Antidepressant in the Management of Hot Flashes in Women Who Have Inadequate Control With an Antidepressant Alone
RATIONALE: Gabapentin may be effective in relieving hot flashes in women who have had breast cancer or who have concerns about taking hormone therapy to treat hot flashes. It is not yet known whether gabapentin is more effective with or without antidepressants in treating hot flashes.
PURPOSE: This randomized phase III trial is studying gabapentin and antidepressants to see how well they work compared to antidepressants alone in treating hot flashes in women who have had breast cancer or who have concerns about taking hormones to treat hot flashes.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to duration of hot flash symptoms (< 9 months vs ≥ 9 months), average frequency of hot flashes per day (2-3 vs 4-9 vs ≥ 10), and antidepressant currently being used (venlafaxine vs paroxetine vs other). Patients are randomized to 1 of 2 treatment arms.
Patients in both arms complete a hot flash diary at baseline and then daily during study treatment.
Quality of life is assessed at baseline and then weekly during study treatment.
PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study within 2 years.
DISEASE CHARACTERISTICS:
History of breast cancer OR a concern about taking hormonal therapy due to a fear of developing breast cancer
Experiencing bothersome hot flashes, defined as patient-reported occurrence ≥ 14 times per week AND sufficiently severe to prompt desire for additional therapeutic intervention despite current use of an antidepressant
Currently (≥ 2 weeks) being treated with a stable dose of an antidepressant
No current evidence of malignant disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Performance status
Life expectancy
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Endocrine therapy
Other
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
West Des Moines, Iowa 50266, United States
Wichita, Kansas 67214, United States
Ann Arbor, Michigan 48106-0995, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422, United States
Missoula, Montana 59802, United States
Wright-Patterson AFB, Ohio 45433-5529, United States
Allentown, Pennsylvania 18105, United States
Anderson, South Carolina 29621, United States
Spartanburg, South Carolina 29303, United States
Sioux Falls, South Dakota 57104, United States