Breast Cancer Clinical Trial
Official title:
Phase III Randomized, Double-Blind, Placebo-Controlled Evaluation of Citalopram for the Treatment of 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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
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