Phase II Study of Soy Protein to Treat Vasomotor Symptoms in Postmenopausal Women Taking Tamoxifen
- Compare the effect of soy protein vs placebo on the daily number and severity of hot
flashes in postmenopausal women with breast disease taking tamoxifen.
- Compare the quality of life in patients treated with these regimens.
- Compare the time to first relief of hot flashes in patients treated with these
- Compare the effect of these regimens on hormonal change in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to duration of hot flashes (less than 9 months vs 9 months or more)
and frequency of hot flashes (7 to 9 per day vs more than 9 per day).
Patients receive oral placebo once per day and keep a hot flash diary daily for 1 week and
are then randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral soy supplement once daily for 12 weeks.
- Arm II: Patients receive oral placebo once daily for 12 weeks. Patients on both arms
complete a daily hot flash diary.
Quality of life is assessed at baseline and at weeks 6 and 12.
Patients are followed for 3 months.
PROJECTED ACCRUAL: A total of 130 patients (65 per treatment arm) will be accrued for this
study within 9 months.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Change in number of daily hot flashes at 3 months from baseline
Gini F. Fleming, MD
University of Chicago
United States: Federal Government
|Memorial Hospital of South Bend||South Bend, Indiana 46601|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|Saint Joseph Regional Medical Center||South Bend, Indiana 46617|
|Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center||Lebanon, New Hampshire 03756-0002|
|Wayne Memorial Hospital, Incorporated||Goldsboro, North Carolina 27534|
|Elkhart General Hospital||Elkhart, Indiana 46515|
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|Lakeland Regional Cancer Care Center - St. Joseph||St. Joseph, Michigan 49085|
|Center for Cancer Therapy at LaPorte Hospital and Health Services||La Porte, Indiana 46350|
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|Center for Cancer Care at OSF Saint Anthony Medical Center||Rockford, Illinois 61108|
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