A Pilot Study to Determine the Effect of Dietary Intervention on Novel Biomarkers of Breast Cancer Risk.
The high incidence of breast cancer, its relatively long development phase and the financial
burden to the NHS in relation to treatment makes it a prime target for dietary preventative
strategies. Epidemiological and experimental investigations suggest several key dietary
components that may reduce breast cancer, in particular isoflavones and selenium. Few
dietary intervention studies have been conducted to investigate putative protective effects,
but with our growing understanding of cancer biology and the application of new -omics
technologies it is now possible to use early biomarkers of risk to assess the potential
efficacy of intervention studies.
In this pilot project, we will employ a combination of disciplines to examine the effect of
dietary intervention in a group of women defined by NICE guidelines as being at increased
risk (moderate-high) of developing breast cancer, using metabolomics to assess the
tractability of biomarkers in response to the dietary intervention. Such trials are urgently
needed to examine the protective effects of diet in women classified at increased risk and
who are still in the 'zone of reversibility'. The results of this study will be used to
justify and optimise larger scale intervention trials and ultimately to develop appropriate
dietary recommendations for the prevention of breast cancer.
A dietary intervention study based on a randomised double-blind parallel design will be
conducted in 30 pre-menopausal women (age 35-50) at moderate to high risk of developing
breast cancer. The metabolomic profiles of urine and serum samples (collected at baseline
and after dietary intervention) will be assessed. Participants will be randomised into two
groups; the placebo group (consuming 6g of non-supplemented chocolate per day) and the
supplemented group (consuming 6g of chocolate containing both soy and selenium per day). The
intervention will last for the duration of one menstrual cycle.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
To determine the effect of supplementation with selenium and isoflavones on biomarkers of breast cancer risk.
Aedin Cassidy, PhD
University of East Anglia
United Kingdom: National Health Service