Soy, Selenium and Breast Cancer Risk - Full Text View

Sponsors and Collaborators:	University of East Anglia Institute of Food Research Big C Local Cancer Research and Care Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Information provided by:	University of East Anglia
ClinicalTrials.gov Identifier:	NCT00555386

Sponsors and Collaborators:

University of East Anglia
Institute of Food Research
Big C Local Cancer Research and Care
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)

Information provided by:

University of East Anglia

ClinicalTrials.gov Identifier:

NCT00555386

Purpose

There is evidence to suggest that some dietary components can reduce the risk of breast cancer. In this pilot study two such components, isoflavones (compounds found in soy products) and selenium, will be given to women classed as at moderate to high risk of the disease. The aim is to determine some novel biomarkers of risk and to see the effect of supplementation on them.

Condition	Intervention
Breast Cancer Risk	Dietary Supplement: Soy and Selenium

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Selenium Proteins, soy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
Official Title:	A Pilot Study to Determine the Effect of Dietary Intervention on Novel Biomarkers of Breast Cancer Risk.

Further study details as provided by University of East Anglia:

Primary Outcome Measures:

To determine the effect of supplementation with selenium and isoflavones on biomarkers of breast cancer risk. [ Time Frame: 25-35 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Identify novel biomarkers of breast cancer risk through metabolomic analysis of samples collect. [ Time Frame: 25-35 days ] [ Designated as safety issue: No ]

Enrollment:	27
Study Start Date:	April 2007
Study Completion Date:	August 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 6g of chocolate (supplemented with selenium and isoflavones) per day for the duration of one menstrual cycle (25-35 days)	Dietary Supplement: Soy and Selenium 6g of chocolate per day Control group with no supplementation Active group 50mg of soy protein isolate + 200µg selenium in the form of MSC
2: Placebo Comparator 6g of chocolate (control) per day for the duration of one menstrual cycle (25-35 days)	Dietary Supplement: Soy and Selenium 6g of chocolate per day Control group with no supplementation Active group 50mg of soy protein isolate + 200µg selenium in the form of MSC

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	35 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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 contraceptives)
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 months
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

United Kingdom, Norfolk
University of East Anglia
Norwich, Norfolk, United Kingdom, NR47TJ
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA

Responsible Party:	University of East Anglia ( Professor Aedin Cassidy )
Study ID Numbers:	R14697, 07/Q0101/10
Study First Received:	November 7, 2007
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00555386
Health Authority:	United Kingdom: National Health Service; United Kingdom: Research Ethics Committee