Citalopram in Treating Postmenopausal Women With Hot Flashes
This study has been completed.
Sponsor:
North Central Cancer Treatment Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00363909
First received: August 10, 2006
Last updated: December 4, 2010
Last verified: April 2007
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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 3 |
| 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:
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) |
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
Show 198 Study LocationsSponsors and Collaborators
North Central Cancer Treatment Group
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:
Publications:
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 May 22, 2013