The Role of Diet and Lifestyle in Breast Cancer Survival

Breast Cancer Clinical Trial

— DietCompLyf  

Official title:

The Role of Diet, Complementary Treatment and Lifestyle in Breast Cancer Progression and Survival

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00701584
• Other study ID #: 1456
• Status: Active, not recruiting
• Phase: N/A
• First received: June 13, 2008
• Last updated: May 19, 2014
• Start date: January 2005
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: University College London Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3390
• Est. completion date: December 2014
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United Kingdom	University of Westminster	London

Sponsors (2)

Lead Sponsor	Collaborator
University College London Hospitals	United Kingdom Clinical Research Collaboration

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the association between phytoestrogens and relapse free survival		Up to 5 years post-diagnosis	No
Secondary	To assess the association between phytoestrogens and event free survival		Up to 5 years post-diagnosis	No
Secondary	To assess the association between phytoestrogens and recurrence free survival		Up to 5 years post-diagnosis	No