Breast Risk Reduction Intermittent Diet Evaluation (BRRIDE) study

Completed

• Conditions: Breast cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN77916487
• Lead Sponsor: niversity Hospital of South Manchester (UHSM) NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-31
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified