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A Pilot Study to Determine the Effect of Dietary Intervention on Novel Biomarkers of Breast Cancer Risk.

35 Years
50 Years
Not Enrolling
Breast Cancer Risk

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Trial Information

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.

Inclusion Criteria:

- Pre menopausal women (age 35-50)at moderate to high risk of breast cancer based on
family history (NICE guidelines)

- Attending Breast Clinic at NNUH

- Willing to consume 6g of chocolate per day for 25-35 days

- Regular menstrual cycle of 25-35 days in length

Exclusion Criteria:

- Current or previous diagnosis of breast cancer or cancer of any other site

- Diagnosis of hypertension (requiring active treatment)/diabetes/ coronary heart
disease/ gastrointestinal disease/ any other systemic disease requiring treatment

- Regularly taking any prescribed medication within the last six months (including oral

- Fitted with a hormone releasing device

- Pregnant or lactating in the previous 12 months

- Using laxatives or antacids more than once a week

- Routinely taking soy or selenium supplements in the last twelve months

- Regularly taking any dietary or herbal supplements in the last six months

- Participation in any intervention study (soy or selenium) in the previous twelve

- Parallel participation in another research study involving either dietary or medical
intervention or sampling of biological fluids/materials

- Blood donation within sixteen weeks of study start/finish

- BMI <18.5 or >35

- Allergy to any chocolate/dairy/soy-based food products

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

To determine the effect of supplementation with selenium and isoflavones on biomarkers of breast cancer risk.

Outcome Time Frame:

25-35 days

Safety Issue:


Principal Investigator

Aedin Cassidy, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of East Anglia


United Kingdom: National Health Service

Study ID:




Start Date:

April 2007

Completion Date:

August 2008

Related Keywords:

  • Breast Cancer Risk
  • Selenium
  • Soy
  • Breast Cancer Risk
  • Breast Neoplasms