NCT00597532CompletedNot Applicable
Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast Tissue: A Randomized Placebo Controlled Study
Memorial Sloan Kettering Cancer Center1 site in 1 country140 target enrollmentStarted: August 1, 2002Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- The primary outcome of the study is comparison of the change in proliferation (Ki67) and apoptosis (TUNEL) in cancerous tissue between the 2 groups.
Study Overview
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.
Detailed Description
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:
- 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.
Study Design and Intervention Plan:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Informed consent obtained
- •Breast mass > .5 cm (determined by mammogram, ultrasound, MRI, or palpable criteria)
- •Core biopsy diagnosis of invasive carcinoma of the breast
Exclusion Criteria
- •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
Arms & Interventions
2
Placebo Comparator
milk protein supplementation 50 grams/day
Intervention: Milk (Dietary Supplement)
1
Experimental
soy (soy protein supplementation 50 grams/day)
Intervention: Soy (Dietary Supplement)
Outcomes
Primary Outcomes
The primary outcome of the study is comparison of the change in proliferation (Ki67) and apoptosis (TUNEL) in cancerous tissue between the 2 groups.
Time Frame: Conclusion of the study
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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