Phase II Study of Soy Protein to Treat Vasomotor Symptoms in Postmenopausal Women Taking Tamoxifen
OBJECTIVES:
- 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.
Interventional
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
Study Chair
University of Chicago
United States: Federal Government
CDR0000069219
NCT00031720
March 2002
April 2006
Name | Location |
---|---|
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 |
Howard Community Hospital | Kokomo, Indiana 46904 |
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 |
Kingsbury Center for Cancer Care at Cheshire Medical Center | Keene, New Hampshire 03431 |
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst, North Carolina 28374 |
Kinston Medical Specialists | Kinston, North Carolina 28501 |
Center for Cancer Care at OSF Saint Anthony Medical Center | Rockford, Illinois 61108 |
Commonwealth Hematology-Oncology, PC - Worcester | Worcester, Massachusetts 01605 |