Overview

This trial is active, not recruiting.

Condition breast cancer
Sponsor University College London Hospitals
Collaborator United Kingdom Clinical Research Collaboration
Start date January 2005
End date August 2010
Trial size 3390 participants
Trial identifier NCT00701584, 1456

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. 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
To assess the association between phytoestrogens and relapse free survival
time frame: Up to 5 years post-diagnosis

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants from 18 years up to 75 years old.

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

Additional Information

Official title The Role of Diet, Complementary Treatment and Lifestyle in Breast Cancer Progression and Survival
Principal investigator Miriam V Dwek, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by University College London Hospitals.