Clinical trial · Interventional
Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast Tissue: A Randomized Placebo Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Milk | Dietary Supplement | — | UNRESOLVED |
| Soy | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- soy (soy protein supplementation 50 grams/day)
- interventionNames
- Dietary Supplement: Soy
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- milk protein supplementation 50 grams/day
- interventionNames
- Dietary Supplement: Milk
Primary outcomes (1)
- measure
- The primary outcome of the study is comparison of the change in proliferation (Ki67) and apoptosis (TUNEL) in cancerous tissue between the 2 groups.
- timeFrame
- Conclusion of the study
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDShike 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 25190728