Soy, Selenium and Breast Cancer Risk

September 24, 2008 updated by: University of East Anglia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
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
Placebo Comparator: 2
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the effect of supplementation with selenium and isoflavones on biomarkers of breast cancer risk.
Time Frame: 25-35 days
25-35 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Identify novel biomarkers of breast cancer risk through metabolomic analysis of samples collect.
Time Frame: 25-35 days
25-35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of East Anglia

Collaborators

Quadram Institute Bioscience
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Big C Local Cancer Research and Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

November 7, 2007

First Submitted That Met QC Criteria

November 7, 2007

First Posted (Estimate)

November 8, 2007

Study Record Updates

Last Update Posted (Estimate)

September 25, 2008

Last Update Submitted That Met QC Criteria

September 24, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R14697
  • 07/Q0101/10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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