A pilot study to determine the effect of dietary intervention on novel biomarkers of breast cancer risk

Completed

• Conditions: Cancer: Breast; Cancer; Breast

• Registration Number: ISRCTN11023622
• Lead Sponsor: Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-28
• Last Update Posted: 30 October 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 30

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

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 <19 or >35
13. Allergy to chocolate/dairy food products or to soy or soy-based food products

Study & Design

• Study Type: Interventional
• Study Design: Not specified