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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00597532 |
To Test Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast Tissue using a Randomized Placebo Controlled Study.
Objectives:
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Dietary Supplement: Soy Dietary Supplement: Milk |
Phase 0 |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast Tissue: A Randomized Placebo Controlled Study |
Enrollment: | 140 |
Study Start Date: | August 2002 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
soy (soy protein supplementation 50 grams/day)
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Dietary Supplement: Soy
soy (soy protein supplementation 50 grams/day)
|
2: Placebo Comparator
milk protein supplementation 50 grams/day
|
Dietary Supplement: Milk
placebo (milk protein supplementation 50 grams/day)
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Patient Population:
Pre and post menopausal women with breast cancer diagnosed by core needle biopsy scheduled to undergo breast cancer resection for an invasive carcinoma.
Objectives:
Study Design and Intervention Plan:
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Moshe Shike, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Moshe Shike, M.D. ) |
Study ID Numbers: | 02-062 |
Study First Received: | December 26, 2007 |
Last Updated: | January 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00597532 |
Health Authority: | United States: Institutional Review Board |
Breast Cancer Soy Milk Supplementation 02-062 |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |