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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00363909 |
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 |
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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: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | Phase III Randomized, Double-Blind, Placebo-Controlled Evaluation of Citalopram for the Treatment of Hot Flashes |
Estimated Enrollment: | 220 |
Study Start Date: | November 2006 |
OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must meet 1 of the following criteria:
History of breast cancer
PATIENT CHARACTERISTICS:
Postmenopausal, as defined by 1 of the following criteria:
PRIOR CONCURRENT THERAPY:
No other concurrent or planned agents for treating hot flashes (e.g., phenobarbital, megestrol, or clonidine)
Investigator: | Debra Barton, RN, PhD, AOCN | Mayo Clinic |
Investigator: | Beth La Vasseur, RN, MS | Saint Joseph Mercy Cancer Center |
Investigator: | Charles L. Loprinzi, MD | Mayo Clinic |
Study ID Numbers: | CDR0000489567, NCCTG-N05C9 |
Study First Received: | August 10, 2006 |
Last Updated: | July 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00363909 History of Changes |
Health Authority: | United States: Federal Government |
psychosocial effects of cancer and its treatment hot flashes breast cancer |
Neurotransmitter Agents Cholinergic Antagonists Skin Diseases Hot Flashes Psychotropic Drugs Breast Neoplasms Cholinergic Agents Citalopram Serotonin Uptake Inhibitors |
Serotonin Muscarinic Antagonists Signs and Symptoms Peripheral Nervous System Agents Dexetimide Antidepressive Agents, Second-Generation Breast Diseases Antidepressive Agents |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Hot Flashes Antiparkinson Agents Cholinergic Agents Signs and Symptoms Neoplasms by Site Therapeutic Uses Antidepressive Agents, Second-Generation |
Dexetimide Antidepressive Agents Breast Diseases Skin Diseases Breast Neoplasms Citalopram Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Neoplasms Serotonin Agents Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents |