Breast CancerDietCompLyfNCT00701584
The Role of Diet and Lifestyle in Breast Cancer Survival
An observational study of Breast Cancer, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
Diet has been found to influence hormone production and metabolism which in turn could affect the incidence of hormone related cancers. Consumption of soy-containing foods, known to be rich in phytoestrogens, is thought to be one of the chemoprotective factors against breast cancer in Asian populations. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 3,390 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2005to Dec 2014
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer clinics in UK
Who may be able to join
- Women with histologically confirmed invasive primary breast cancer grades I to III.
- age up to and including 75 years old
Who cannot join
- Previous cancer with the exception of basal cell carcinoma
- Concomitant primary cancer
- Bilateral cancer of the breast
- Psychological problems
- Cognitive impairment
- Poor understanding of English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Diet, Complementary Treatment and Lifestyle in Breast Cancer Progression and Survival
Diet has been found to influence hormone production and metabolism which in turn could affect the incidence of hormone related cancers. Consumption of soy-containing foods, known to be rich in phytoestrogens, is thought to be one of the chemoprotective factors against breast cancer in Asian populations. Phytoestrogens have a wide range of metabolic effects and may have a role in effecting breast cancer risk. Although there is mounting evidence of the positive influence of phytoestrogens on breast cancer risk, very little research has been carried out in humans as to the effects of phytoestrogens on breast cancer recurrence and survival. The DietCompLyf study aims to explore this effect by carrying out an observational study in 3,000 breast cancer women in the UK. The effects of diet, lifestyle practices and use of complementary treatments will also be investigated. Participants are recruited 9-15 months post-diagnosis and followed up for 5 years. Questionnaires as well as blood and urine samples are collected annually.
Read the detailed description
Women matching the eligibility criteria are consented at breast cancer follow-up hospital visits. Blood and urine samples are then collected and questionnaires are provided for the participants to take away and return within 4 weeks. The process of sample collection and questionnaire provision is repeated for visit at years 3 and 5.
Year 2 and 4 study visit vary in that questionnaires including a 7 day food diary are sent to participants at home to be filled in 7 days before their scheduled follow-up appointment. At hospital, blood and urine samples are collected as usual.
- Conditions
- Breast Cancer
- Keywords
- Phytoestrogens, Isoflavones, Lignans, Breast cancer survival, breast cancer recurrence
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the association between phytoestrogens and relapse free survival
Measured: Up to 5 years post-diagnosis
Secondary outcomes (2)
To assess the association between phytoestrogens and event free survival
Measured: Up to 5 years post-diagnosis
To assess the association between phytoestrogens and recurrence free survival
Measured: Up to 5 years post-diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJan 2005
- Primary completionAug 2010
- Study completionDec 2014 (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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,390 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- United Kingdom Clinical Research Collaboration
- Investigators
- Miriam V Dwek, PhD, Principal investigator, University of Westminster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701584
- Sponsor's protocol ID
- 1456
- Acronym
- DietCompLyf
- Status last verified
- May 2014
- First submitted
- 13 Jun 2008
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. 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 Progression and Survival
- ClinicalTrials.gov ID
- NCT00701584
- Acronym / sponsor ID
- DietCompLyf / 1456
- Conditions
- Breast Cancer
- Keywords
- Phytoestrogens, Isoflavones, Lignans, Breast cancer survival, breast cancer recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,390 participants (actual)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Collaborators
- United Kingdom Clinical Research Collaboration
- Study start
- Jan 2005
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 19 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.
Diet has been found to influence hormone production and metabolism which in turn could affect the incidence of hormone related cancers. Consumption of soy-containing foods, known to be rich in phytoestrogens, is thought to be one of the chemoprotective factors against breast cancer in Asian populations. Phytoestrogens have a wide range of metabolic effects and may have a role in effecting breast cancer risk. Although there is mounting evidence of the positive influence of phytoestrogens on breast cancer risk, very little research has been carried out in humans as to the effects of phytoestrogens on breast cancer recurrence and survival. The DietCompLyf study aims to explore this effect by carrying out an observational study in 3,000 breast cancer women in the UK. The effects of diet, lifestyle practices and use of complementary treatments will also be investigated. Participants are recruited 9-15 months post-diagnosis and followed up for 5 years. Questionnaires as well as blood and urine samples are collected annually.
Detailed description
Women matching the eligibility criteria are consented at breast cancer follow-up hospital visits. Blood and urine samples are then collected and questionnaires are provided for the participants to take away and return within 4 weeks. The process of sample collection and questionnaire provision is repeated for visit at years 3 and 5.
Year 2 and 4 study visit vary in that questionnaires including a 7 day food diary are sent to participants at home to be filled in 7 days before their scheduled follow-up appointment. At hospital, blood and urine samples are collected as usual.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer clinics in UK
Key inclusion criteria (2 listed)
- Women with histologically confirmed invasive primary breast cancer grades I to III.
- age up to and including 75 years old
Key exclusion criteria (6 listed)
- Previous cancer with the exception of basal cell carcinoma
- Concomitant primary cancer
- Bilateral cancer of the breast
- Psychological problems
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the association between phytoestrogens and relapse free survival
Time frame: Up to 5 years post-diagnosis
2 secondary outcomes
To assess the association between phytoestrogens and event free survival
Time frame: Up to 5 years post-diagnosis
To assess the association between phytoestrogens and recurrence free survival
Time frame: Up to 5 years post-diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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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.
Miriam V Dwek, PhD principal investigator
University of Westminster
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?
The sponsor lists 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 May 2014. 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?
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 assess the association between phytoestrogens and relapse free survival (time frame: Up to 5 years post-diagnosis). 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 20 May 2014.