Breast CancerNCT00691509
Dietary Phytoestrogens, Complementary and Alternative Medicine, and Lifestyle in Predicting Survival of Women With Breast Cancer
An observational study of Breast Cancer, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
RATIONALE: Eating a diet rich in phytoestrogens may slow the growth of breast cancer cells and prevent further tumor progression. Learning about the lifestyles of women with breast cancer, their intake of phytoestrogens derived from food and supplements, and their use of complementary or alternative medicine (CAM)… Read more about this study
- Who is it for?
- Ages Up to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- gene expression analysis, polymorphism analysis and high performance liquid chromatography
- How many people
- 2,300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2005to Dec 2010
- Phase
- Observational
- 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 Up to 75 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive primary breast cancer
- Grade I to III disease
- No bilateral disease
- Completed active treatment for primary breast cancer within 9 months to 15 months after diagnosis
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- No prior cancer except basal cell carcinoma
- No other concurrent primary cancer
- No cognitive impairment
- No psychological problems (e.g., severe endogenous depression)
- Able to understand English well
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College Hospital
London, England, NW1 2BU
Contact Person, 44-207-679-9396, a.leathem@ucl.ac.uk
About this study
Official title: The Role of Diet, Complementary Treatment and Lifestyle in Breast Cancer Survival
RATIONALE: Eating a diet rich in phytoestrogens may slow the growth of breast cancer cells and prevent further tumor progression. Learning about the lifestyles of women with breast cancer, their intake of phytoestrogens derived from food and supplements, and their use of complementary or alternative medicine (CAM) practices may help doctors learn more about breast cancer.
PURPOSE: This clinical trial is studying the effect of dietary and supplemental phytoestrogens and CAM therapies in preventing progression and improving survival of women with breast cancer.
Read the detailed description
OBJECTIVES:
- To determine if phytoestrogen intake affects breast cancer progression and survival in women with breast cancer.
- To consider the influence of other phytochemicals on breast cancer progression in these patients, using samples of patient blood and urine and patient-derived data.
- To develop a database of food, dietary supplements, and phytoestrogens based on data derived from these patients.
- To consider influences of diet and dietary supplements on quality of life of these patients.
- To measure 17 phytoestrogens in blood and urine samples from these patients.
OUTLINE: This is a multicenter study.
Patients undergo blood and urine sample collection once a year for 5 years during routine clinical follow-up after breast cancer diagnosis and treatment. Blood samples are frozen for future analysis of body hormones, tumor markers, and immune reactions, as well as vitamins and plant chemicals reflecting patient diet and supplements. Blood samples are also analyzed for genetic studies of cancer risk factors and polymorphisms. Urine samples are analyzed for the presence of phytoestrogens and their metabolites by immunoassays, high performance liquid chromatography (HPLC), and mass spectrometry. Some samples are analyzed for estrogenic potency by the estrogen receptor-mediated chemical activated luciferase gene expression test to assess total plasma levels of estrogen-mimics not previously detected by the other tests. Phytochemicals are also assessed.
Patients also complete a series of questionnaires once each year for 5 years and an EPIC 7-day Food Diary in years 2 and 4 to assess the role of diet and lifestyle in breast cancer survival. The questionnaires include the EORTC Quality of Life-30 to assess lifestyle; the General Health Questionnaire 12 to assess general health and levels of anxiety; and up to two Food Frequency questionnaires to assess habitual dietary intake of phytoestrogens. Patients are also asked about their use of dietary supplements and complementary and alternative medicine.
- Conditions
- Breast Cancer
- Being tested
- gene expression analysis, polymorphism analysis, high performance liquid chromatography, laboratory biomarker analysis, mass spectrometry
- Keywords
- breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gene expression analysisGenetic
polymorphism analysisGenetic
high performance liquid chromatographyOther
laboratory biomarker analysisOther
mass spectrometryOther
questionnaire administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startJan 2005
- Primary completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Observational
- Enrolment
- 2,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Investigators
- Anthony Leathem, MD, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691509
- Sponsor's protocol ID
- CDR0000589004
- Other IDs
- UCLH-BCRG-DIETCOMPLYF-1456, EU-20823
- Status last verified
- Jun 2008
- First submitted
- 4 Jun 2008
- Last updated
- 26 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Diet, Complementary Treatment and Lifestyle in Breast Cancer Survival
- ClinicalTrials.gov ID
- NCT00691509
- Acronym / sponsor ID
- CDR0000589004
- Conditions
- Breast Cancer
- Keywords
- breast cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Dec 2010 (estimated)
- First posted
- 5 Jun 2008 (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.
RATIONALE: Eating a diet rich in phytoestrogens may slow the growth of breast cancer cells and prevent further tumor progression. Learning about the lifestyles of women with breast cancer, their intake of phytoestrogens derived from food and supplements, and their use of complementary or alternative medicine (CAM) practices may help doctors learn more about breast cancer.
PURPOSE: This clinical trial is studying the effect of dietary and supplemental phytoestrogens and CAM therapies in preventing progression and improving survival of women with breast cancer.
Detailed description
OBJECTIVES:
- To determine if phytoestrogen intake affects breast cancer progression and survival in women with breast cancer.
- To consider the influence of other phytochemicals on breast cancer progression in these patients, using samples of patient blood and urine and patient-derived data.
- To develop a database of food, dietary supplements, and phytoestrogens based on data derived from these patients.
- To consider influences of diet and dietary supplements on quality of life of these patients.
- To measure 17 phytoestrogens in blood and urine samples from these patients.
OUTLINE: This is a multicenter study.
Patients undergo blood and urine sample collection once a year for 5 years during routine clinical follow-up after breast cancer diagnosis and treatment. Blood samples are frozen for future analysis of body hormones, tumor markers, and immune reactions, as well as vitamins and plant chemicals reflecting patient diet and supplements. Blood samples are also analyzed for genetic studies of cancer risk factors and polymorphisms. Urine samples are analyzed for the presence of phytoestrogens and their metabolites by immunoassays, high performance liquid chromatography (HPLC), and mass spectrometry. Some samples are analyzed for estrogenic potency by the estrogen receptor-mediated chemical activated luciferase gene expression test to assess total plasma levels of estrogen-mimics not previously detected by the other tests. Phytochemicals are also assessed.
Patients also complete a series of questionnaires once each year for 5 years and an EPIC 7-day Food Diary in years 2 and 4 to assess the role of diet and lifestyle in breast cancer survival. The questionnaires include the EORTC Quality of Life-30 to assess lifestyle; the General Health Questionnaire 12 to assess general health and levels of anxiety; and up to two Food Frequency questionnaires to assess habitual dietary intake of phytoestrogens. Patients are also asked about their use of dietary supplements and complementary and alternative medicine.
Study design
Who may qualify
- Ages
- Up to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| gene expression analysis | Genetic | – |
| polymorphism analysis | Genetic | – |
| high performance liquid chromatography | Other | – |
| laboratory biomarker analysis | Other | – |
| mass spectrometry | Other | – |
| questionnaire administration | Other | – |
Primary outcome
Relapse-free survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2013.
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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.
Anthony Leathem, MD principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University College London Hospitals at 1 site 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?
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: status not confirmed, as of the sponsor's last update on 26 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2013.