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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
United Kingdom Clinical Research Collaboration
Information provided by:
University College London Hospitals
ClinicalTrials.gov Identifier:
NCT00701584
First received: June 13, 2008
Last updated: May 19, 2014
Last verified: May 2014
  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

Resource links provided by NLM:


Further study details as provided by University College London Hospitals:

Primary Outcome Measures:
  • To assess the association between phytoestrogens and relapse free survival [ Time Frame: Up to 5 years post-diagnosis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the association between phytoestrogens and event free survival [ Time Frame: Up to 5 years post-diagnosis ] [ Designated as safety issue: No ]
  • To assess the association between phytoestrogens and recurrence free survival [ Time Frame: Up to 5 years post-diagnosis ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Breast cancer clinics in UK

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701584

Locations
United Kingdom
University of Westminster
London, United Kingdom, W1W 6UW
Sponsors and Collaborators
University College London Hospitals
United Kingdom Clinical Research Collaboration
Investigators
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: May 19, 2014
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 October 01, 2014