Soy, Selenium and Breast Cancer Risk

Breast Cancer Risk Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00555386
• Other study ID #: R14697
• Secondary ID: 07/Q0101/10
• Status: Completed
• Phase: N/A
• First received: November 7, 2007
• Last updated: September 24, 2008
• Start date: April 2007
• Est. completion date: August 2008

Study information

• Verified date: September 2008
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 50 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer Risk
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Institute of Food Research	Norwich	Norfolk
United Kingdom	Norfolk and Norwich University Hospital	Norwich	Norfolk
United Kingdom	University of East Anglia	Norwich	Norfolk

Sponsors (4)

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

Country where clinical trial is conducted

United Kingdom, 

References & Publications (33)

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Solanky KS, Bailey NJ, Beckwith-Hall BM, Davis A, Bingham S, Holmes E, Nicholson JK, Cassidy A. Application of biofluid 1H nuclear magnetic resonance-based metabonomic techniques for the analysis of the biochemical effects of dietary isoflavones on human plasma profile. Anal Biochem. 2003 Dec 15;323(2):197-204. — View Citation

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Whanger PD. Selenium and its relationship to cancer: an update. Br J Nutr. 2004 Jan;91(1):11-28. Review. — View Citation

Xiang H, Schevzov G, Gunning P, Williams HM, Silink M. A comparative study of growth-inhibitory effects of isoflavones and their metabolites on human breast and prostate cancer cell lines. Nutr Cancer. 2002;42(2):224-32. — View Citation

Xu X, Duncan AM, Merz BE, Kurzer MS. Effects of soy isoflavones on estrogen and phytoestrogen metabolism in premenopausal women. Cancer Epidemiol Biomarkers Prev. 1998 Dec;7(12):1101-8. — View Citation

Yang J, Xu G, Zheng Y, Kong H, Pang T, Lv S, Yang Q. Diagnosis of liver cancer using HPLC-based metabonomics avoiding false-positive result from hepatitis and hepatocirrhosis diseases. J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Dec 25;813(1-2):59-65. — View Citation

Zhang J, Svehlíková V, Bao Y, Howie AF, Beckett GJ, Williamson G. Synergy between sulforaphane and selenium in the induction of thioredoxin reductase 1 requires both transcriptional and translational modulation. Carcinogenesis. 2003 Mar;24(3):497-503. — View Citation

* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effect of supplementation with selenium and isoflavones on biomarkers of breast cancer risk.		25-35 days	No
Secondary	Identify novel biomarkers of breast cancer risk through metabolomic analysis of samples collect.		25-35 days	No