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PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement in reducing hot flashes in postmenopausal women who are receiving tamoxifen for breast disease such as ductal hyperplasia or breast cancer.
- 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 regimens.
- 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, Control: Placebo Control, Masking: Double-Blind, Primary Purpose: Supportive Care
soy protein isolate, placebo
Center for Cancer Care at OSF Saint Anthony Medical Center
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-07-23T21:55:08-0400
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