The Role of Diet, Complementary Treatment and Lifestyle in Breast Cancer Progression and Survival
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 3,390
- 试验地点
- 1
- 主要终点
- To assess the association between phytoestrogens and relapse free survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with histologically confirmed invasive primary breast cancer grades I to III.
- •age up to and including 75 years old
排除标准
- •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
结局指标
主要结局
To assess the association between phytoestrogens and relapse free survival
时间窗: Up to 5 years post-diagnosis
次要结局
- To assess the association between phytoestrogens and event free survival(Up to 5 years post-diagnosis)
- To assess the association between phytoestrogens and recurrence free survival(Up to 5 years post-diagnosis)