Clinical trial NCT00701584: The Role of Diet and Lifestyle in Breast Cancer Survival
Official title: The Role of Diet, Complementary Treatment and Lifestyle in Breast Cancer Progression and Survival
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Phytoestrogens
Isoflavones
Lignans
Breast cancer survival
breast cancer recurrence
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
Collaborators: name: United Kingdom Clinical Research Collaboration
First posted: 2008-06-19
Enrollment: 3390
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer clinics in UK

Brief 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.

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 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

Primary outcomes:
measure: To assess the association between phytoestrogens and relapse free survival
timeFrame: Up to 5 years post-diagnosis
Secondary outcomes:
measure: To assess the association between phytoestrogens and event free survival
timeFrame: Up to 5 years post-diagnosis
measure: To assess the association between phytoestrogens and recurrence free survival
timeFrame: Up to 5 years post-diagnosis
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University of Westminster
Study officials:
affiliation: University of Westminster
name: Miriam V Dwek, PhD
role: PRINCIPAL_INVESTIGATOR
References: