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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00363909 |
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Date of registration:
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10/08/2006 |
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Primary sponsor: |
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Public title:
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Citalopram in Treating Postmenopausal Women With Hot Flashes
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Scientific title:
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Phase III Randomized, Double-Blind, Placebo-Controlled Evaluation of Citalopram for the Treatment of Hot Flashes |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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220 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00363909 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
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Countries of recruitment
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United States
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Contacts
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Name:
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Charles L. Loprinzi, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Name:
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Debra Barton, RN, PhD, AOCN, FAAN |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Name:
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Beth La Vasseur, RN, MS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Saint Joseph Mercy Cancer Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Hot Flashes
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Psychosocial Effects of Cancer and Its Treatment
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Intervention(s)
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Drug: citalopram hydrobromide
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Procedure: psychosocial assessment and care
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Procedure: quality-of-life assessment
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Primary Outcome(s)
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Difference in average hot flash score from baseline until week 7 of treatment
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Secondary Outcome(s)
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Mood- and hot flash-related daily interference with activities
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Toxicity
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Secondary ID(s)
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CDR0000489567
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NCCTG-N05C9
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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