The Role of Diet and Lifestyle in Breast Cancer Survival (DietCompLyf)
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Purpose
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.
| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Role of Diet, Complementary Treatment and Lifestyle in Breast Cancer Progression and Survival |
Serum, plasma, buffy coat, urine
| Enrollment: | 3390 |
| Study Start Date: | January 2005 |
| Estimated Study Completion Date: | December 2014 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
breast cancer clinics in UK
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
Contacts and Locations| United Kingdom | |
| University of Westminster | |
| London, United Kingdom, W1W 6UW | |
| Principal Investigator: | Miriam V Dwek, PhD | University of Westminster |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director of Research and Developement, UCL Hospitals NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT00701584 History of Changes |
| Other Study ID Numbers: | 1456 |
| Study First Received: | June 13, 2008 |
| Last Updated: | September 10, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University College London Hospitals:
|
Phytoestrogens Isoflavones Lignans Breast cancer survival breast cancer recurrence |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013