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NCT00363909

Citalopram in Treating Postmenopausal Women With Hot Flashes

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Hot Flashes Psychosocial Effects of Cancer and Its Treatment

Keywords

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psychosocial effects of cancer and its treatment hot flashes breast cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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low-dose citalopram hydrobromide

Patients receive 1 tablet of oral citalopram 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.

Group Type EXPERIMENTAL

citalopram hydrobromide

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

citalopram hydrobromide

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

citalopram hydrobromide

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Interventions

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citalopram hydrobromide

Intervention Type DRUG

placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Debra Barton, RN, PhD, AOCN, FAAN

Role: STUDY_CHAIR

Mayo Clinic

Locations

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MBCCOP - Medical College of Georgia Cancer Center

Augusta, Georgia, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

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St. Joseph Medical Center

Bloomington, Illinois, United States

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Graham Hospital

Canton, Illinois, United States

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Memorial Hospital

Carthage, Illinois, United States

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Eureka Community Hospital

Eureka, Illinois, United States

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Galesburg Clinic

Galesburg, Illinois, United States

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Galesburg Cottage Hospital

Galesburg, Illinois, United States

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Mason District Hospital

Havana, Illinois, United States

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Hopedale Medical Complex

Hopedale, Illinois, United States

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Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

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Kewanee Hospital

Kewanee, Illinois, United States

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McDonough District Hospital

Macomb, Illinois, United States

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BroMenn Regional Medical Center

Normal, Illinois, United States

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Community Cancer Center

Normal, Illinois, United States

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Community Hospital of Ottawa

Ottawa, Illinois, United States

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Oncology Hematology Associates of Central Illinois, PC - Ottawa

Ottawa, Illinois, United States

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Cancer Treatment Center at Pekin Hospital

Pekin, Illinois, United States

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Proctor Hospital

Peoria, Illinois, United States

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CCOP - Illinois Oncology Research Association

Peoria, Illinois, United States

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Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria, Illinois, United States

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Methodist Medical Center of Illinois

Peoria, Illinois, United States

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OSF St. Francis Medical Center

Peoria, Illinois, United States

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Illinois Valley Community Hospital

Peru, Illinois, United States

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Perry Memorial Hospital

Princeton, Illinois, United States

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St. Margaret's Hospital

Spring Valley, Illinois, United States

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Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

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CCOP - Carle Cancer Center

Urbana, Illinois, United States

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St. Francis Hospital and Health Centers - Beech Grove Campus

Beech Grove, Indiana, United States

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Elkhart General Hospital

Elkhart, Indiana, United States

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Howard Community Hospital at Howard Regional Health System

Kokomo, Indiana, United States

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Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte, Indiana, United States

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Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

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Reid Hospital & Health Care Services, Incorporated

Richmond, Indiana, United States

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CCOP - Northern Indiana CR Consortium

South Bend, Indiana, United States

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Memorial Hospital of South Bend

South Bend, Indiana, United States

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Saint Joseph Regional Medical Center

South Bend, Indiana, United States

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McFarland Clinic, PC

Ames, Iowa, United States

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