Clinical trial · Interventional
Soy, Selenium and Breast Cancer Risk
A Pilot Study to Determine the Effect of Dietary Intervention on Novel Biomarkers of Breast Cancer Risk.
NCT00555386CI-TRIAL-00001696completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Risk | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Soy and Selenium | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- 6g of chocolate (supplemented with selenium and isoflavones) per day for the duration of one menstrual cycle (25-35 days)
- interventionNames
- Dietary Supplement: Soy and Selenium
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- 6g of chocolate (control) per day for the duration of one menstrual cycle (25-35 days)
- interventionNames
- Dietary Supplement: Soy and Selenium
Primary outcomes (1)
- measure
- To determine the effect of supplementation with selenium and isoflavones on biomarkers of breast cancer risk.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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
References
Publications (33)
- BACKGROUNDAkbaraly 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. doi: 10.1373/clinchem.2005.055301. Epub 2005 Aug 25. PMID 16123147
- BACKGROUNDBarnes S. Phytoestrogens and breast cancer. Baillieres Clin Endocrinol Metab. 1998 Dec;12(4):559-79. doi: 10.1016/s0950-351x(98)80004-9. PMID 10384813
- BACKGROUNDBathen 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. PMID 10953302
- BACKGROUNDCassidy 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. doi: 10.1079/bjn19950160. PMID 7577895
- BACKGROUNDCassidy 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. doi: 10.1093/ajcn/60.3.333. PMID 8074062
- BACKGROUNDDoll 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. PMID 7017215
- BACKGROUNDDuncan 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. doi: 10.1210/jcem.84.1.5387. PMID 9920082
- BACKGROUNDDuncan 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.