Citalopram in Treating Postmenopausal Women With Hot Flashes

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Citalopram; Dexetimide

Criteria

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