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Soy, Selenium and Breast Cancer Risk

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00555386
First Posted: November 8, 2007
Last Update Posted: September 25, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Quadram Institute
Big C Local Cancer Research and Care
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Information provided by:
University of East Anglia
  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

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

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • Identify novel biomarkers of breast cancer risk through metabolomic analysis of samples collect. [ Time Frame: 25-35 days ]

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
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 50 Years   (Adult)
Sexes 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555386


Locations
United Kingdom
Institute of Food Research
Norwich, Norfolk, United Kingdom, NR4 7UA
Norfolk and Norwich University Hospital
Norwich, Norfolk, United Kingdom, NR4 7UY
University of East Anglia
Norwich, Norfolk, United Kingdom, NR47TJ
Sponsors and Collaborators
University of East Anglia
Quadram Institute
Big C Local Cancer Research and Care
Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
Investigators
Principal Investigator: Aedin Cassidy, PhD University of East Anglia
  More Information

Publications:
Akbaraly NT, Arnaud J, Hininger-Favier I, Gourlet V, Roussel AM, Berr C. Selenium and mortality in the elderly: results from the EVA study. Clin Chem. 2005 Nov;51(11):2117-23. Epub 2005 Aug 25.
Barnes S. Phytoestrogens and breast cancer. Baillieres Clin Endocrinol Metab. 1998 Dec;12(4):559-79. Review.
Bathen TF, Engan T, Krane J, Axelson D. Analysis and classification of proton NMR spectra of lipoprotein fractions from healthy volunteers and patients with cancer or CHD. Anticancer Res. 2000 Jul-Aug;20(4):2393-408.
Cassidy A, Bingham S, Setchell K. Biological effects of isoflavones in young women: importance of the chemical composition of soyabean products. Br J Nutr. 1995 Oct;74(4):587-601.
Cassidy A, Bingham S, Setchell KD. Biological effects of a diet of soy protein rich in isoflavones on the menstrual cycle of premenopausal women. Am J Clin Nutr. 1994 Sep;60(3):333-40.
Doll R, Peto R. The causes of cancer: quantitative estimates of avoidable risks of cancer in the United States today. J Natl Cancer Inst. 1981 Jun;66(6):1191-308. Review.
Duncan AM, Merz BE, Xu X, Nagel TC, Phipps WR, Kurzer MS. Soy isoflavones exert modest hormonal effects in premenopausal women. J Clin Endocrinol Metab. 1999 Jan;84(1):192-7.
Duncan AM, Merz-Demlow BE, Xu X, Phipps WR, Kurzer MS. Premenopausal equol excretors show plasma hormone profiles associated with lowered risk of breast cancer. Cancer Epidemiol Biomarkers Prev. 2000 Jun;9(6):581-6.
El-Bayoumy K, Sinha R. Mechanisms of mammary cancer chemoprevention by organoselenium compounds. Mutat Res. 2004 Jul 13;551(1-2):181-97. Review.
Fan S, Meng Q, Auborn K, Carter T, Rosen EM. BRCA1 and BRCA2 as molecular targets for phytochemicals indole-3-carbinol and genistein in breast and prostate cancer cells. Br J Cancer. 2006 Feb 13;94(3):407-26.
Grover PL, Martin FL. The initiation of breast and prostate cancer. Carcinogenesis. 2002 Jul;23(7):1095-102. Review.
Hu YJ, Diamond AM. Role of glutathione peroxidase 1 in breast cancer: loss of heterozygosity and allelic differences in the response to selenium. Cancer Res. 2003 Jun 15;63(12):3347-51.
Ip C. Lessons from basic research in selenium and cancer prevention. J Nutr. 1998 Nov;128(11):1845-54. Review.
Katdare M, Osborne M, Telang NT. Soy isoflavone genistein modulates cell cycle progression and induces apoptosis in HER-2/neu oncogene expressing human breast epithelial cells. Int J Oncol. 2002 Oct;21(4):809-15.
Lee SO, Nadiminty N, Wu XX, Lou W, Dong Y, Ip C, Onate SA, Gao AC. Selenium disrupts estrogen signaling by altering estrogen receptor expression and ligand binding in human breast cancer cells. Cancer Res. 2005 Apr 15;65(8):3487-92.
Li J, Orlandi R, White CN, Rosenzweig J, Zhao J, Seregni E, Morelli D, Yu Y, Meng XY, Zhang Z, Davidson NE, Fung ET, Chan DW. Independent validation of candidate breast cancer serum biomarkers identified by mass spectrometry. Clin Chem. 2005 Dec;51(12):2229-35. Epub 2005 Oct 13.
Lü J, Jiang C. Selenium and cancer chemoprevention: hypotheses integrating the actions of selenoproteins and selenium metabolites in epithelial and non-epithelial target cells. Antioxid Redox Signal. 2005 Nov-Dec;7(11-12):1715-27. Review.
Messina MJ, Loprinzi CL. Soy for breast cancer survivors: a critical review of the literature. J Nutr. 2001 Nov;131(11 Suppl):3095S-108S. Review.
Odunsi K, Wollman RM, Ambrosone CB, Hutson A, McCann SE, Tammela J, Geisler JP, Miller G, Sellers T, Cliby W, Qian F, Keitz B, Intengan M, Lele S, Alderfer JL. Detection of epithelial ovarian cancer using 1H-NMR-based metabonomics. Int J Cancer. 2005 Feb 20;113(5):782-8.
Paglia DE, Valentine WN. Studies on the quantitative and qualitative characterization of erythrocyte glutathione peroxidase. J Lab Clin Med. 1967 Jul;70(1):158-69.
Shah YM, Al-Dhaheri M, Dong Y, Ip C, Jones FE, Rowan BG. Selenium disrupts estrogen receptor (alpha) signaling and potentiates tamoxifen antagonism in endometrial cancer cells and tamoxifen-resistant breast cancer cells. Mol Cancer Ther. 2005 Aug;4(8):1239-49.
Rinaldi S, Peeters PH, Berrino F, Dossus L, Biessy C, Olsen A, Tjonneland A, Overvad K, Clavel-Chapelon F, Boutron-Ruault MC, Téhard B, Nagel G, Linseisen J, Boeing H, Lahmann PH, Trichopoulou A, Trichopoulos D, Koliva M, Palli D, Panico S, Tumino R, Sacerdote C, van Gils CH, van Noord P, Grobbee DE, Bueno-de-Mesquita HB, Gonzalez CA, Agudo A, Chirlaque MD, Barricarte A, Larrañaga N, Quiros JR, Bingham S, Khaw KT, Key T, Allen NE, Lukanova A, Slimani N, Saracci R, Riboli E, Kaaks R. IGF-I, IGFBP-3 and breast cancer risk in women: The European Prospective Investigation into Cancer and Nutrition (EPIC). Endocr Relat Cancer. 2006 Jun;13(2):593-605.
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.
Solanky KS, Bailey NJ, Beckwith-Hall BM, Bingham S, Davis A, Holmes E, Nicholson JK, Cassidy A. Biofluid 1H NMR-based metabonomic techniques in nutrition research - metabolic effects of dietary isoflavones in humans. J Nutr Biochem. 2005 Apr;16(4):236-44.
Trock BJ, Hilakivi-Clarke L, Clarke R. Meta-analysis of soy intake and breast cancer risk. J Natl Cancer Inst. 2006 Apr 5;98(7):459-71.
Tsubura A, Uehara N, Kiyozuka Y, Shikata N. Dietary factors modifying breast cancer risk and relation to time of intake. J Mammary Gland Biol Neoplasia. 2005 Jan;10(1):87-100. Review.
Whanger PD. Selenium and its relationship to cancer: an update. Br J Nutr. 2004 Jan;91(1):11-28. Review.
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.
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.
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.
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.
Nutritional aspects of the development of cancer. Report of the Working Group on Diet and Cancer of the Committee on Medical Aspects of Food and Nutrition Policy. Rep Health Soc Subj (Lond). 1998;48:i-xiv, 1-274. Review.
Clemons M, Goss P. Estrogen and the risk of breast cancer. N Engl J Med. 2001 Jan 25;344(4):276-85. Review. Erratum in: N Engl J Med 2001 Jun 7;344(23):1804.

Responsible Party: Professor Aedin Cassidy, University of East Anglia
ClinicalTrials.gov Identifier: NCT00555386     History of Changes
Other Study ID Numbers: R14697
07/Q0101/10
First Submitted: November 7, 2007
First Posted: November 8, 2007
Last Update Posted: September 25, 2008
Last Verified: September 2008

Keywords provided by University of East Anglia:
Selenium
Soy
Breast Cancer Risk

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Selenium
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Micronutrients
Growth Substances


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