Status:
COMPLETED
Citalopram in Treating Postmenopausal Women With Hot Flashes
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Hot Flashes
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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 postmenopau...
Detailed Description
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...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Must meet 1 of the following criteria:
- History of breast cancer
- No current malignant disease
- No history of breast cancer and refused estrogen replacement therapy due to perceived increased risk of breast cancer
- Bothersome hot flashes, defined as hot flashes ≥ 14 times/week and of sufficient severity to make the patient desire therapeutic intervention
- Presence of hot flashes ≥ 1 month prior to study entry
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Female
- Postmenopausal, as defined by 1 of the following criteria:
- Absence of a menstrual period in the past 12 months
- Bilateral oophorectomy
- Absence of a menstrual period in the past 6 months with follicle-stimulating hormone (FSH) level \> 40 mIU/mL
- ECOG performance status 0-1
- Life expectancy ≥ 6 months
- Willing to provide blood samples during study participation
- No history of allergic or other adverse reactions to citalopram hydrobromide or other selective serotonin reuptake inhibitors (SSRIs)
- No documented mania or hypomania
- PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior and no concurrent antineoplastic chemotherapy
- At least 4 weeks since prior and no concurrent androgens, estrogens, or progestational agents
- At least 3 months since prior antidepressant use, including Hypericum perforatum (St. John's wort)
- Concurrent tamoxifen, raloxifene, or aromatase inhibitors allowed if on a constant dose for ≥ 4 weeks and continuing medication during study period
- No other concurrent or planned agents for treating hot flashes (e.g., phenobarbital, megestrol, or clonidine)
- Stable dose of vitamin E allowed as long as it was started \> 30 days prior to study entry
- Concurrent soy allowed
- Concurrent gabapentin allowed for reasons other than hot flashes if on a constant dose for ≥ 1 month and continuing during study period
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT00363909
Start Date
November 1 2006
End Date
December 1 2010
Last Update
December 13 2016
Active Locations (198)
Enter a location and click search to find clinical trials sorted by distance.
1
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912
2
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
3
St. Joseph Medical Center
Bloomington, Illinois, United States, 61701
4
Graham Hospital
Canton, Illinois, United States, 61520