Spots Global Cancer Trial Database for Soy Protein Supplement In Treating Hot Flashes in Postmenopausal Women Receiving Tamoxifen for Breast Disease
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Trial Identification
Brief Title: Soy Protein Supplement In Treating Hot Flashes in Postmenopausal Women Receiving Tamoxifen for Breast Disease
Official Title: Phase II Study of Soy Protein to Treat Vasomotor Symptoms in Postmenopausal Women Taking Tamoxifen
Study ID: NCT00031720
Study Description
Brief Summary: RATIONALE: Soy protein supplement may be effective in reducing hot flushes in postmenopausal women who are receiving tamoxifen for breast disease. PURPOSE: Randomized phase II trial to determine the effectiveness of soy protein supplement in reducing hot flushes in postmenopausal women who are receiving tamoxifen for breast disease such as ductal hyperplasia or breast cancer.
Detailed Description: 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). For more information regarding the treatment regimens, please see the treatment arms section. Primary objectives: 1. To compare the effect of daily soy supplementation versus placebo on the daily number of hot flushes experienced by postmenopausal women taking tamoxifen measured at three months from baseline 2. To compare the effect of daily soy supplementation versus placebo on hot flush severity as measured by the average daily hot flash score in this population of women measured at three months from baseline Secondary objectives: 1. To evaluate the effect of soy supplementation as compared to women randomized to placebo on quality of life as measured by the Medical Outcomes Study (MOS) sleep subscale, the Mental Health Inventory (MHI), the CES-D Short Form, the Menopause and Reproductive Health Questionnaire, and the General Quality of Life Form 2. To measure the effect of soy supplementation as compared to women randomized to placebo on serum isoflavones, estradiol, SHBG, IGF1 and IGFBP3 levels as measures of hormonal change 3. To estimate the effect of daily soy supplementation versus placebo on the time to first relief of hot flushes A total of 112 patients accrued on this study. Patients were followed 6 months post-randomization.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Center for Cancer Care at OSF Saint Anthony Medical Center, Rockford, Illinois, United States
Elkhart General Hospital, Elkhart, Indiana, United States
Howard Community Hospital, Kokomo, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services, La Porte, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Memorial Hospital of South Bend, South Bend, Indiana, United States
Saint Joseph Regional Medical Center, South Bend, Indiana, United States
Commonwealth Hematology-Oncology, PC - Worcester, Worcester, Massachusetts, United States
Lakeland Regional Cancer Care Center - St. Joseph, St. Joseph, Michigan, United States
Kingsbury Center for Cancer Care at Cheshire Medical Center, Keene, New Hampshire, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States
Wayne Memorial Hospital, Incorporated, Goldsboro, North Carolina, United States
Kinston Medical Specialists, Kinston, North Carolina, United States
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center, Pinehurst, North Carolina, United States
Contact Details
Name: Gini F. Fleming, MD
Affiliation: University of Chicago
Role: STUDY_CHAIR
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