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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00031720 |
RATIONALE: Soy protein supplement may be effective in reducing hot flashes 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 flashes in postmenopausal women who are receiving tamoxifen for breast disease such as ductal hyperplasia or breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer Cancer-Related Problem/Condition |
Drug: placebo Drug: soy protein isolate |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | Phase II Study of Soy Protein to Treat Vasomotor Symptoms in Postmenopausal Women Taking Tamoxifen |
Study Start Date: | March 2002 |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral soy supplement once daily for 12 weeks.
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Drug: soy protein isolate
Given orally
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Arm II: Placebo Comparator
Patients receive oral placebo once daily for 12 weeks.
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Drug: placebo
Given orally
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OBJECTIVES:
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.
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.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast disease, including one of the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Postmenopausal, defined by one of the following:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
No concurrent systemic hormone replacement therapy or vaginal estrogen creams
Radiotherapy:
Surgery:
Other:
No concurrent vitamin E, clonidine, belladonna derivative, or other soy supplement for hot flashes
United States, Illinois | |
Center for Cancer Care at OSF Saint Anthony Medical Center | |
Rockford, Illinois, United States, 61108 | |
United States, Indiana | |
CCOP - Northern Indiana CR Consortium | |
South Bend, Indiana, United States, 46601 | |
Center for Cancer Therapy at LaPorte Hospital and Health Services | |
La Porte, Indiana, United States, 46350 | |
Saint Joseph Regional Medical Center | |
South Bend, Indiana, United States, 46617 | |
Howard Community Hospital | |
Kokomo, Indiana, United States, 46904 | |
Memorial Hospital of South Bend | |
South Bend, Indiana, United States, 46601 | |
Elkhart General Hospital | |
Elkhart, Indiana, United States, 46515 | |
United States, Massachusetts | |
Commonwealth Hematology-Oncology, PC - Worcester | |
Worcester, Massachusetts, United States, 01605 | |
United States, Michigan | |
Lakeland Regional Cancer Care Center - St. Joseph | |
St. Joseph, Michigan, United States, 49085 | |
United States, New Hampshire | |
Kingsbury Center for Cancer Care at Cheshire Medical Center | |
Keene, New Hampshire, United States, 03431 | |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03756-0002 | |
United States, North Carolina | |
Wayne Memorial Hospital, Incorporated | |
Goldsboro, North Carolina, United States, 27534 | |
Kinston Medical Specialists | |
Kinston, North Carolina, United States, 28501 | |
FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | |
Pinehurst, North Carolina, United States, 28374 |
Study Chair: | Gini F. Fleming, MD | University of Chicago |
Study ID Numbers: | CDR0000069219, CALGB-79805, NCI-P02-0206 |
Study First Received: | March 8, 2002 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00031720 |
Health Authority: | United States: Federal Government |
lobular breast carcinoma in situ stage I breast cancer stage II breast cancer stage IIIA breast cancer |
recurrent breast cancer ductal breast carcinoma in situ hot flashes |
Carcinoma, Lobular Skin Diseases Carcinoma in Situ Hot Flashes Breast Neoplasms Carcinoma, Ductal, Breast |
Carcinoma, Intraductal, Noninfiltrating Tamoxifen Recurrence Breast Diseases Carcinoma |
Neoplasms Neoplasms by Site |