The Role of Diet and Lifestyle in Breast Cancer Survival (DietCompLyf)

May 19, 2014 updated by: University College London Hospitals

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Actual)

3390

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W1W 6UW
        • University of Westminster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Breast cancer clinics in UK

Description

Inclusion Criteria:

  • Women with histologically confirmed invasive primary breast cancer grades I to III.
  • age up to and including 75 years old

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the association between phytoestrogens and relapse free survival
Time Frame: Up to 5 years post-diagnosis
Up to 5 years post-diagnosis

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the association between phytoestrogens and event free survival
Time Frame: Up to 5 years post-diagnosis
Up to 5 years post-diagnosis
To assess the association between phytoestrogens and recurrence free survival
Time Frame: Up to 5 years post-diagnosis
Up to 5 years post-diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College London Hospitals

Collaborators

United Kingdom Clinical Research Collaboration

Investigators

  • Principal Investigator: Miriam V Dwek, PhD, University of Westminster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

August 1, 2010

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria

June 13, 2008

First Posted (Estimate)

June 19, 2008

Study Record Updates

Last Update Posted (Estimate)

May 20, 2014

Last Update Submitted That Met QC Criteria

May 19, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1456

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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