Citalopram in Treating Postmenopausal Women With Hot Flashes - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00363909

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Hot Flashes Psychosocial Effects of Cancer and Its Treatment	Drug: citalopram hydrobromide Procedure: psychosocial assessment and care Procedure: quality-of-life assessment	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care
Official Title:	Phase III Randomized, Double-Blind, Placebo-Controlled Evaluation of Citalopram for the Treatment of Hot Flashes

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Benzetimide Dexetimide Citalopram hydrobromide Citalopram Escitalopram Escitalopram oxalate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Difference in average hot flash score from baseline until week 7 of treatment

Secondary Outcome Measures:

Toxicity
Mood- and hot flash-related daily interference with activities

Estimated Enrollment:	220
Study Start Date:	November 2006
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

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 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.

PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363909

Show 198 Study Locations

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

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

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Barton DL, Lavasseur BI, Sloan JA, Stawis AN, Flynn KA, Dyar M, Johnson DB, Atherton PJ, Diekmann B, Loprinzi CL. Phase III, Placebo-Controlled Trial of Three Doses of Citalopram for the Treatment of Hot Flashes: NCCTG Trial N05C9. J Clin Oncol. 2010 May 24; [Epub ahead of print]

Barton DL, LaVasseur B, Sloan JA, et al.: A phase III trial evaluating three doses of citalopram for hot flashes: NCCTG trial N05C9. [Abstract] J Clin Oncol 26 (Suppl 15): A-9538, 2008.

ClinicalTrials.gov Identifier:	NCT00363909 History of Changes
Other Study ID Numbers:	CDR0000489567, NCCTG-N05C9
Study First Received:	August 10, 2006
Last Updated:	December 4, 2010
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

psychosocial effects of cancer and its treatment
hot flashes
breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Hot Flashes
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Citalopram
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on February 09, 2012