Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast Tissue: A Randomized Placebo Controlled Study
1 other identifier
interventional
140
1 country
1
Brief Summary
To Test Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast Tissue using a Randomized Placebo Controlled Study. Objectives:
- To determine (by immunohistochemistry) whether specific cellular markers and gene products associated with breast carcinoma can be altered by soy therapy.
- To identify genes that can be altered by soy therapy in normal and neoplastic breast tissues by unbiased gene expression analysis using microarrays.
- To compare specific cellular markers and pathways (immunohistochemistry), and gene expression using microarrays in normal and cancerous breast tissue.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Aug 2002
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
December 26, 2007
CompletedFirst Posted
Study publicly available on registry
January 18, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedApril 13, 2016
April 1, 2016
13.7 years
December 26, 2007
April 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome of the study is comparison of the change in proliferation (Ki67) and apoptosis (TUNEL) in cancerous tissue between the 2 groups.
Conclusion of the study
Study Arms (2)
1
EXPERIMENTALsoy (soy protein supplementation 50 grams/day)
2
PLACEBO COMPARATORmilk protein supplementation 50 grams/day
Interventions
Eligibility Criteria
You may qualify if:
- Informed consent obtained
- Breast mass \> .5 cm (determined by mammogram, ultrasound, MRI, or palpable criteria)
- Core biopsy diagnosis of invasive carcinoma of the breast
You may not qualify if:
- History of active malignancy within previous two years (except for non-melanoma skin cancer and history of breast cancer).
- Regular soy consumption (consumption of more than 3 serving of soy or soy products/supplements per week)
- Allergy to soy or milk protein
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Publications (1)
Shike M, Doane AS, Russo L, Cabal R, Reis-Filho JS, Gerald W, Cody H, Khanin R, Bromberg J, Norton L. The effects of soy supplementation on gene expression in breast cancer: a randomized placebo-controlled study. J Natl Cancer Inst. 2014 Sep 4;106(9):dju189. doi: 10.1093/jnci/dju189. Print 2014 Sep.
PMID: 25190728DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Moshe Shike, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2007
First Posted
January 18, 2008
Study Start
August 1, 2002
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
April 13, 2016
Record last verified: 2016-04