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Oral Clonidine in Postmenopausal Patients with Breast Cancer Experiencing Tamoxifen-Induced Hot Flashes: A University of Rochester Cancer Center Community Clinical Oncology Program Study

Kishan J. Pandya, MD; Richard F. Raubertas, PhD; Patrick J. Flynn, MD; Harry E. Hynes, MD; Richard J. Rosenbluth, MD; Jeffrey J. Kirshner, MD; H. Irving Pierce, MD; Vladimir Dragalin, PhD; and Gary R. Morrow, PhD, MS
[+] Article, Author, and Disclosure 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@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.

Ann Intern Med. 2000;132(10):788-793. doi:10.7326/0003-4819-132-10-200005160-00004
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Hot flashes—a collective term that includes many vasomotor symptoms, such as a feeling of warmth, redness of the face and upper body, sweating, and dizziness—are the most frequent menopausal symptom. Approximately 60% to 70% of women undergoing the climacteric report hot flashes (1). Hot flashes are also the most common side effect associated with use of the antiestrogen tamoxifen; in a recent study, 57% of 1318 women with breast cancer who were receiving the drug reported hot flashes (2). Although most women tolerate this symptom and are able to remain active, others find it distressing. Hot flashes have been reported to interfere with daily activities and sleep, and some women have considered discontinuing therapy or have been less compliant with their daily tamoxifen regimen. These problems have become more pronounced because long-term tamoxifen therapy is now advocated for early-stage breast cancer. It is important to address the continuing problem of vasomotor side effects associated with tamoxifen therapy.

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Figure 1.
Flow of participants.

*Two patients were ineligible, and three declined to participate.

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Figure 2.
Changes in hot flash symptoms and quality-of-life score compared with baseline values, by treatment group and study week.

For each week, the left-hand boxplot with squares represents the clonidine group and the right-hand boxplot with circles represents the placebo group. One observation at week 12 in the placebo group is not included in the plot of hot flash duration because the patient reported a mean duration of 1 minute at baseline and 15 minutes at 12 weeks (an increase of 1400%).

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Summary for Patients

Using the Medicine Clonidine To Treat Hot Flashes in Breast Cancer Patients Taking Tamoxifen

The summary below is from the full report titled “Oral Clonidine in Postmenopausal Patients with Breast Cancer Experiencing Tamoxifen-Induced Hot Flashes: A University of Rochester Cancer Center Community Clinical Oncology Program Study.” It is in the 16 May 2000 issue of Annals of Internal Medicine (volume 132, pages 788-793). The authors are K.J. Pandya, R.F. Raubertas, P.J. Flynn, H.E. Hynes, R.J. Rosenbluth, J.J. Kirshner, H.I. Pierce, V. Dragalin, and G.R. Morrow.


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