Citalopram in Treating Postmenopausal Women With Hot Flashes
RATIONALE: Citalopram may help relieve hot flashes in women who had or have not had breast cancer. It is not yet known which dose of citalopram is more effective in treating hot flashes in postmenopausal women.
PURPOSE: This randomized phase III trial is studying three different doses of citalopram to compare how well they work in treating postmenopausal women with hot flashes.
Psychosocial Effects of Cancer and Its Treatment
Drug: citalopram hydrobromide
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
|Study Design:||Allocation: Randomized
Primary Purpose: Supportive Care
|Official Title:||Phase III Randomized, Double-Blind, Placebo-Controlled Evaluation of Citalopram for the Treatment of Hot Flashes|
- Difference in average hot flash score from baseline until week 7 of treatment
- Mood- and hot flash-related daily interference with activities
|Study Start Date:||November 2006|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- Evaluate the efficacy of three different doses of citalopram hydrobromide on hot flash scores in postmenopausal women with a history of breast cancer or in postmenopausal women who do not wish to take estrogen replacement therapy for fear of increased risk of breast cancer.
- Compare the side effect profile of these regimens in these patients.
- Compare the effects of these regimens on the secondary outcome of mood and interference with activities from hot flashes.
- Determine if CYP2C19 and CYP2D6 polymorphisms predict efficacy of various doses of citalopram hydrobromide.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (18-49 years vs ≥ 50 years), tamoxifen (yes vs no), selective estrogen-receptor modulators (SERMs) (yes vs no), aromatase inhibitors (yes vs no), duration of hot flashes (< 9 months vs ≥ 9 months), and frequency of hot flashes per day (< 4 vs 4-9 vs ≥ 10). Patients are randomized to 1 of 4 treatment arms.
- Arm I (low-dose citalopram hydrobromide): Patients receive 1 tablet of oral citalopram once daily in weeks 2-7.
- Arm II (medium-dose citalopram hydrobromide): Patients receive 1 tablet of oral citalopram once daily in week 2 and 2 tablets once daily in weeks 3-7.
- Arm III (high-dose citalopram hydrobromide): Patients receive 1 tablet of oral citalopram once daily in week 2, 2 tablets once daily in week 3, and 3 tablets once daily in weeks 4-7.
- Arm IV (placebo): Patients receive 1-3 placebo tablets once daily in weeks 2-7. All patients complete a diary of hot flash incidence in weeks 1-7 and undergo blood collection periodically during study treatment for translational research studies.
A Symptom Experience diary is completed weekly and Profile of Mood States and Hot Flash-Related Interference Scale questionnaires are completed at baseline and in week 7.
PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.
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|Investigator:||Debra Barton, RN, PhD, AOCN, FAAN||Mayo Clinic|
|Investigator:||Beth La Vasseur, RN, MS||Saint Joseph Mercy Cancer Center|
|Investigator:||Charles L. Loprinzi, MD||Mayo Clinic|