Breast Cancer RiskNCT00555386
Soy, Selenium and Breast Cancer Risk
A study testing Soy and Selenium in people with Breast Cancer Risk, run by University of East Anglia at 3 sites in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 35 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Risk
- What is being tested?
- Soy and Selenium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Apr 2007to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Institute of Food Research
Norwich, Norfolk, NR4 7UA
Norfolk and Norwich University Hospital
Norwich, Norfolk, NR4 7UY
University of East Anglia
Norwich, Norfolk, NR47TJ
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer Risk
- Being tested
- Soy and Selenium
- Keywords
- Selenium, Soy, Breast Cancer Risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy and SeleniumDietary supplement
6g of chocolate per day Control group with no supplementation Active group 50mg of soy protein isolate + 200µg selenium in the form of MSC
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 6g of chocolate (supplemented with selenium and isoflavones) per day for the duration of one menstrual cycle (25-35 days) Receives: Dietary Supplement: Soy and Selenium |
| 2 | Placebo comparator | 6g of chocolate (control) per day for the duration of one menstrual cycle (25-35 days) Receives: Dietary Supplement: Soy and Selenium |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of supplementation with selenium and isoflavones on biomarkers of breast cancer risk.
Measured: 25-35 days
Secondary outcomes (1)
Identify novel biomarkers of breast cancer risk through metabolomic analysis of samples collect.
Measured: 25-35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2007 (estimated)
- Study startApr 2007
- Primary completionMay 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Quadram Institute Bioscience, Big C Local Cancer Research and Care, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Investigators
- Aedin Cassidy, PhD, Principal investigator, University of East Anglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555386
- Sponsor's protocol ID
- R14697
- Other IDs
- 07/Q0101/10
- Status last verified
- Sep 2008
- First submitted
- 7 Nov 2007
- Last updated
- 25 Sep 2008
- Results posted
- No
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. doi: 10.1373/clinchem.2005.055301. Epub 2005 Aug 25.
PubMed 16123147Barnes S. Phytoestrogens and breast cancer. Baillieres Clin Endocrinol Metab. 1998 Dec;12(4):559-79. doi: 10.1016/s0950-351x(98)80004-9.
PubMed 10384813Bathen 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.
PubMed 10953302Cassidy 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.
PubMed 7577895Cassidy 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.
PubMed 8074062Doll 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.
PubMed 7017215Duncan 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.
PubMed 9920082Duncan 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.
PubMed 10868692El-Bayoumy K, Sinha R. Mechanisms of mammary cancer chemoprevention by organoselenium compounds. Mutat Res. 2004 Jul 13;551(1-2):181-97. doi: 10.1016/j.mrfmmm.2004.02.023.
PubMed 15225592Fan 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. doi: 10.1038/sj.bjc.6602935.
PubMed 16434996Grover PL, Martin FL. The initiation of breast and prostate cancer. Carcinogenesis. 2002 Jul;23(7):1095-102. doi: 10.1093/carcin/23.7.1095.
PubMed 12117765Hu 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.
PubMed 12810669Ip C. Lessons from basic research in selenium and cancer prevention. J Nutr. 1998 Nov;128(11):1845-54. doi: 10.1093/jn/128.11.1845.
PubMed 9808633Katdare 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.
PubMed 12239620Lee 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. doi: 10.1158/0008-5472.CAN-04-3267.
PubMed 15833885
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Effect of Dietary Intervention on Novel Biomarkers of Breast Cancer Risk.
- ClinicalTrials.gov ID
- NCT00555386
- Acronym / sponsor ID
- R14697
- Conditions
- Breast Cancer Risk
- Keywords
- Selenium, Soy, Breast Cancer Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Quadram Institute Bioscience, Big C Local Cancer Research and Care, Clinical Research and Trials Unit (Norfolk & Norwich University Hospital, UK)
- Study start
- Apr 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 8 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Dietary Supplement: Soy and Selenium6g of chocolate (supplemented with selenium and isoflavones) per day for the duration of one menstrual cycle (25-35 days) |
| 2 | Placebo comparator | Dietary Supplement: Soy and Selenium6g of chocolate (control) per day for the duration of one menstrual cycle (25-35 days) |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy and Selenium6g of chocolate per day Control group with no supplementation Active group 50mg of soy protein isolate + 200µg selenium in the form of MSC | Dietary supplement | 1, 2 |
Primary outcome
To determine the effect of supplementation with selenium and isoflavones on biomarkers of breast cancer risk.
Time frame: 25-35 days
1 secondary outcome
Identify novel biomarkers of breast cancer risk through metabolomic analysis of samples collect.
Time frame: 25-35 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2008.
- Background: PubMed 16123147Akbaraly 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.
- Background: PubMed 10384813Barnes S. Phytoestrogens and breast cancer. Baillieres Clin Endocrinol Metab. 1998 Dec;12(4):559-79. doi: 10.1016/s0950-351x(98)80004-9.
- Background: PubMed 10953302Bathen 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.
- Background: PubMed 7577895Cassidy 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.
- Background: PubMed 8074062Cassidy 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.
- Background: PubMed 7017215Doll 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.
- Background: PubMed 9920082Duncan 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.
- Background: PubMed 10868692Duncan 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.
- Background: PubMed 15225592El-Bayoumy K, Sinha R. Mechanisms of mammary cancer chemoprevention by organoselenium compounds. Mutat Res. 2004 Jul 13;551(1-2):181-97. doi: 10.1016/j.mrfmmm.2004.02.023.
- Background: PubMed 16434996Fan 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. doi: 10.1038/sj.bjc.6602935.
- Background: PubMed 12117765Grover PL, Martin FL. The initiation of breast and prostate cancer. Carcinogenesis. 2002 Jul;23(7):1095-102. doi: 10.1093/carcin/23.7.1095.
- Background: PubMed 12810669Hu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aedin Cassidy, PhD principal investigator
University of East Anglia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soy and Selenium in people with Breast Cancer Risk, run by University of East Anglia at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the effect of supplementation with selenium and isoflavones on biomarkers of breast cancer risk. (time frame: 25-35 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00555386, which also lists 33 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2008.