Cancer: Breast Cancer Breast
Conditions
Interventions
The study will be led by Prof Aedin Cassidy, School of Medicine, Health Policy and Practice (MED) at the University of East Anglia in collaboration with Mr Simon Pain, Consultant Breast Surgeon at the
Sponsors
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Pre-menopausal women (age 35-50) at moderate to high risk of developing breast cancer. Study participants will be recruited from the breast clinic at NNUH and will be eligible for recruitment onto the study if they have one or more of the medium or high risk family histories as defined by the NICE guidelines (May 2004).
Exclusion criteria
Exclusion criteria: Added 15/05/2008: 1. Current or previous diagnosis of breast cancer as defined by invasive ductal carcinoma or invasive lobular carcinoma 2. Current or previous diagnosis of cancer or metastases at any site other than breast 3. Diagnosis of hypertension requiring active treatment or diabetes 4. Coronary heart disease 5. Gastrointestinal disease (or other systemic disease requiring active treatment) 6. Regularly taking any prescribed medication that may affect the study data 7. Currently taking oral contraceptives or fitted with a hormone releasing device or coil 8. Pregnant or lactating in the previous 12 months or regularly using antacids or laxatives (at least once a week). 9. Routinely taking soy or selenium supplements in the previous 12 months or regularly taking any other dietary or herbal supplements and unwilling to discontinue their use for the duration of the study 10. Participation in a selenium or soy intervention study in the previous 12 months, or parallel participation in another research study involving either dietary or medical intervention or sampling of biological fluids/materials. 11. Blood donation within 4 weeks of the first study sample and planned donation within 4 weeks of the last study sample 12. BMI 35 13. Allergy to chocolate/dairy food products or to soy or soy-based food products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of urinary and plasma metabolic profiles. | — |
Secondary
| Measure | Time frame |
|---|---|
| Added 15/05/2008: 1. To quantify selenium status by measuring plasma glutathione peroxidase and selenium concentrations before and after dietary supplementation with selenium-methylselenocysteine (MSC) 2. To measure the plasma appearance of a range of isoflavone phytoestrogens (genistein, daidzein, glycitein, equol and O-desmethylangolensin) following dietary supplementation with soy protein isolate 3. To quantify insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3), collagen type I and collagen type IV concentrations in plasma/serum (biomarkers recently reported to be associated with breast cancer risk) pre- and post dietary intervention | — |
Countries
United Kingdom
Outcome results
None listed