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16 May 2000 | Volume 132 Issue 10 | Pages 788-793
Background: Hot flashes are the most frequently reported side effect of tamoxifen treatment. Although hormones are an effective treatment, their safety is questionable in women with breast cancer. It is therefore important to evaluate nonhormonal treatments for hot flashes.
Objective: To evaluate the effectiveness of oral clonidine for control of hot flashes associated with tamoxifen therapy in postmenopausal women with breast cancer.
Design: Randomized, double-blind, placebo-controlled clinical trial.
Setting: University of Rochester Cancer Center Community Clinical Oncology Program.
Patients: 194 postmenopausal women with breast cancer who were receiving adjuvant tamoxifen therapy.
Intervention: Oral clonidine hydrochloride, 0.1 mg/d, or placebo for 8 weeks.
Measurements: In a daily diary, patients recorded number, duration, and severity of hot flashes and overall quality-of-life score (on a 10-point scale) during a 1-week baseline period and during the 4th, 8th, and 12th weeks of the study.
Results: Patients in the placebo and treatment groups were similar in age, duration of tamoxifen use, reported frequency and duration of hot flashes at baseline, and dropout rates. One hundred forty-nine patients completed 12 weeks of follow-up. The mean decrease in hot flash frequency was greater in the clonidine group than in the placebo group after 4 weeks of treatment (37% compared with 20% [95% CI for difference, 7% to 27%]) and 8 weeks of treatment (38% compared with 24% [CI for difference, 3% to 27%]). Patients receiving clonidine were more likely than patients receiving placebo to report difficulty sleeping (41% compared with 21%; P = 0.02). A significant difference was seen in the mean change in quality-of-life scores (0.3 points in the clonidine group compared with –0.2 points in the placebo group; P = 0.02) at 8 weeks, although the median difference was 0 in both groups.
Conclusion: Oral clonidine, 0.1 mg/d, is effective against tamoxifen-induced hot flashes in postmenopausal women with breast cancer.
Author and Article Information
From University of Rochester Cancer Center Community Clinical Oncology Program Research Base, Rochester, New York; Metro-Minnesota Community Clinical Oncology Program, St. Louis Park, Minnesota; Wichita Community Clinical Oncology Program, Wichita, Kansas; Northern New Jersey Community Clinical Oncology Program, Hackensack, New Jersey; Syracuse Hematology-Oncology Community Clinical Oncology Program, Syracuse, New York; and Northwest Community Clinical Oncology Program, Tacoma, Washington.
Acknowledgments: The authors thank the following additional affiliates of the University of Rochester Cancer Center Community Clinical Oncology Program Research Base: Ernest Franklin, MD; David K. King, MD; Kevin P. Mulvey, MD; Brian Issell, MD; Raymond S. Lord, MD; Richard H. Wheeler, MD; John Roberts, MD; and Paul Weiden, MD.
Grant Support: By National Cancer Institute (CA37420).
Requests for Single Reprints: Kishan J. Pandya, MD, University of Rochester Cancer Center, 601 Elmwood Ave, Box 704, Rochester, NY 14642.
Requests To Purchase Bulk Reprints (minimum, 100 copies): the Reprints Coordinator; phone, 215-351-2657; e-mail, reprints{at}mail.acponline.org.
Current Author Addresses: Drs. Pandya and Morrow: University of Rochester Cancer Center, 601 Elmwood Avenue, Box 704, Rochester, NY 14642.
Dr. Raubertas: Department of Biostatistics, University of Rochester, 601 Elmwood Avenue, Box 630, Rochester, NY 14642.
Dr. Flynn: 3800 Park Nicollet Boulevard, St. Louis Park, MN 55416-2699.
Dr. Hynes: 929 North St. Frances, Wichita, KS 67201-1358.
Dr. Rosenbluth: Northern New Jersey Cancer Center, 5 Summit Avenue, Hackensack, NJ 07601-1992.
Dr. Kirshner: 1000 East Genesee Street, Suite 400, Syracuse, NY 13210-1853.
Dr. Pierce: 1003 South Fifth Street, Second Floor, Tacoma, WA 98405-4210.
Dr. Dragalin: 1250 South Collegeville Road, Collegeville, PA 19426-0989.
Author Contributions: Conception and design: K.J. Pandya, P.J. Flynn, R.F. Raubertas, J.J. Kirshner, G.R. Morrow.
Analysis and interpretation of the data: K.J. Pandya, R.F. Raubertas, V. Dragalin, G.R. Morrow.
Drafting of the article: K.J. Pandya.
Critical revision of the article for important intellectual content: K.J. Pandya, R.F. Raubertas, J.J. Kirshner, G.R. Morrow.
Final approval of the article: K.J. Pandya, P.J. Flynn, J.J. Kirshner, G.R. Morrow.
Provision of study materials or patients: K.J. Pandya, P.J. Flynn, H.E. Hynes, R.J. Rosenbluth, J.J. Kirshner, H.I. Pierce.
Statistical expertise: R.F. Raubertas, V. Dragalin.
Administrative, technical, or logistic support: G.R. Morrow.
Collection and assembly of data: G.R. Morrow. ARTICLE
Oral Clonidine in Postmenopausal Patients with Breast Cancer Experiencing Tamoxifen-Induced Hot Flashes: A University of Rochester Cancer Center Community Clinical Oncology Program Study
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