The Breast Risk Reduction Intermittent Diet Evaluation (BRRIDE) study: The effect of an intermittent very low calories diet on gene expression in breast cells and surrogate blood markers of risk amongst women at increased risk of breast cancer

niversity Hospital of South Manchester (UHSM) NHS Foundation Trust (UK)0 个研究点目标入组 25 人开始时间: 2012年7月31日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Family history of breast cancer (lifetime risk >1 in 6)
•2. Body mass index 24?35 kg/ m2
•3. Aged between 35 and 45 years
•2. Regular menstrual cycles (not perimenopausal).
•3. Breast density >30% determined by mammogram (to ensure epithelium is obtained in core biopsy)
•5. Sedentary (<20 minutes moderate activity twice/ week) to avoid any confounding effects of exercise
•6. Able to record diet diaries
•7. Normal mammogram in the last 2 years

•1. Already successfully dieting or losing weight
•2. Long term medical condition which may affect white cell function; i.e. autoimmune, inflammatory, allergy
•3. Consumption of diets or supplements high in phytoestrogens
•4. Previous use of tamoxifen or other selective oestrogen receptor modulators
•5. Current use of anticoagulant or anti-platelet drugs including regular aspirin
•6. Previous diagnosis of breast cancer or other cancers except non-melanoma skin cancer or cervical intra-epithelial neoplasia
•7. Previous atypical ductal hyperplasia or Atypical Lobular Hyperplasia
•8. Pregnant or planning a pregnancy in the next few months
•9. Irregular menstrual cycles with the possibility of perimenopausal status
•10. Use of hormonal oral contraceptives or progesterone only contraceptives (Intra-uterine system (?Mirena?), injectable or implantable progesterones) currently or in the past 6 months.
•11. Serious co-morbidity that would in the opinion of the investigator confound the results of the study or put the patient at risk, such as diabetes mellitus, ischaemic heart disease, thyroid disease
•12. Psychiatric morbidity (eating disorders, depression or alcoholism)
•13. Previous breast enhancement or breast reduction surgery
•14. Received inoculations or donated blood within 2 months of the start of the study

发起方

niversity Hospital of South Manchester (UHSM) NHS Foundation Trust (UK)