Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Citalopram in Treating Postmenopausal Women With Hot Flashes

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	18 and over	NCI	NCCTG-N05C9 NCT00363909

Objectives

Primary

1. 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

1. Compare the side effect profile of these regimens in these patients.
2. Compare the effects of these regimens on the secondary outcome of mood and interference with activities from hot flashes.
3. Determine if CYP2C19 and CYP2D6 polymorphisms predict efficacy of various doses of citalopram hydrobromide.

Entry 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

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

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

Expected Enrollment

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

Outcomes

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

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

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.

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Debra Barton, RN, PhD, AOCN, FAAN, Study coordinator		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Beth La Vasseur, RN, MS, Study coordinator		Ph: 734-712-5658; 888-474-4673 Email: lavasseb@trinity-health.org
Charles Loprinzi, MD, Study coordinator		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Registry Information
Official Title		Phase III Randomized, Double-Blind, Placebo-Controlled Evaluation of Citalopram for the Treatment of Hot Flashes
Trial Start Date		2006-11-03
Registered in ClinicalTrials.gov		NCT00363909
Date Submitted to PDQ		2006-06-06
Information Last Verified		2007-04-13
NCI Grant/Contract Number		CA37404

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