Gabapentin With or Without Antidepressants in Treating Hot Flashes in Women Who Have Had Breast Cancer or Have Concerns About Taking Hormone Therapy
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||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|
- Hot flash reduction by diary record at 4 weeks
- Toxicity by questionnaires at 4 weeks
|Study Start Date:||November 2004|
|Primary Completion Date:||April 2007 (Final data collection date for primary outcome measure)|
- Compare the efficacy of gabapentin with vs without an antidepressant, as measured by the frequency and intensity of hot flashes, in patients with a history of breast cancer or a concern about taking hormonal therapy due to a fear of developing breast cancer.
- Compare adverse events in patients treated with these regimens.
- Correlate a reduction in hot flash scores with improvement in quality of life and related outcomes in patients treated with these regimens.
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.
- Arm I: Patients continue to receive the same antidepressant (as before study entry) on weeks 1-5. During weeks 2-5, patients also receive oral gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity.
- Arm II: Patients receive gabapentin as in arm I. Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone (per arm I schedule).
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.
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|Study Chair:||Charles L. Loprinzi, MD||Mayo Clinic|
|Investigator:||Debra Barton, RN, PhD, AOCN, FAAN||Mayo Clinic|