RCT OF PLANT-BASED DIET IN BREAST CANCER RECURRENCE

描述（由申请人提供）：本提案旨在完成和结束女性健康饮食和生活（WHEL）研究，这是一项正在进行的多中心（7个临床站点）随机对照试验，旨在研究植物性饮食模式会影响额外乳腺癌事件和死亡率的假设。该研究招募了3109名女性，她们在4年内被初步诊断为I期（bbb1cm）、II期和IIIA期乳腺癌，并完成了标准治疗。该研究采用了一种行为改变理论驱动的综合和量身定制的干预措施，以激励干预组参与者大幅增加每日蔬菜、水果和纤维的摄入量，同时减少饮食模式中的脂肪，这将导致循环类胡萝卜素的大量增加。这项研究包括定期测量自我报告的饮食和补充剂摄入量、个人习惯、生活质量和健康状况，同时记录身体测量，收集和储存血浆、血清、灰褐色皮毛和洗涤红细胞样本。10张原始肿瘤组织切片。每六个月与所有参与者联系一次，进行健康状况评估，并审查所有报告的癌症事件和死亡的医疗记录。所有复发的女性都被鼓励留在研究中，有一个灵活的评估时间表，以减轻参与者的负担。在研究的第4年，我们评估了补充和替代医学服务的使用情况。这项研究目前达到了它的所有目标。在基线时，每组报告每天大约吃三份蔬菜。一年后，干预组报告的每日蔬菜/蔬菜汁摄入量为7.1份，对照组为3.1份，而对于那些至少参与研究两年的人，每日蔬菜摄入量为6.4份，干预组为3.1份，对照组为3.1份。循环类胡萝卜素维持变化为：a-胡萝卜素+89%干预-3%对照；[3-胡萝卜素水平+57%干预组叶黄素+23%对照组+7%。]该研究将使用意向治疗分析来评估研究干预是否对整个研究样本以及55岁以下和55岁以上随机分组的结果产生影响。对于每个分析，将确定四种选择：饮食模式减少复发和死亡率；它降低了复发率，但没有降低死亡率；它没有减少复发率，但降低了死亡率，对复发率和死亡率都没有影响。该研究还将调查饮食模式的不同组成部分、循环类胡萝卜素和研究终点之间的关系。

DESCRIPTION (PROVIDED BY APPLICANT): This proposal is to complete and close out the Women's Healthy Eating and Living (WHEL) Study, an ongoing multi-center (7 clinical sites) randomized controlled trial examining the hypothesis that a plant-based dietary pattern affects additional breast cancer events and mortality. The study has enrolled 3109 women who were within 4 years of a primary diagnosis of Stage I (>1 cm), Stage II and Stage IIIA breast cancer and who had completed standard therapy. The study uses a behavior-change- theory-driven comprehensive and tailored intervention to motivate intervention group participants to substantially increase daily consumption of vegetables fruit and fiber while reducing fat in a dietary pattern that should result in a large increase in circulating carotenoids. The study includes regular measures of self-reported dietary and supplement intake, personal habits, quality of life and health status along with recording of physical measures and the collection and storage of samples of plasma, serum, buffy coat and washed red blood cells. 10 tissue slides are stored from the original tumor. All participants are contacted every six months for a health status assessment and medical records are reviewed for all reported cancer events as well as deaths. All women who recur are encouraged to stay in the study with a flexible schedule for assessments to reduce participant burden. At year 4 of the study we assess the use of complementary and alternative medicine services. The study is currently meeting all of its goals. At baseline, each group reported consuming approximately three vegetable servings/day. At one year the reported daily vegetable/vegetable juice servings were 7.1 for the intervention vs. 3.1 for the control and, for those who had been at least 2 years in the study, daily vegetable servings were at 6.4 Intervention vs. 3.1 Control. The maintained change in circulating carotenoids is: a-carotene +89% Intervention -3% comparison; [3-carotene levels +57% Intervention in comparison with lutein +23% Intervention and +7% in the comparison group. The study will use an intent-to-treat analysis to assess whether the study intervention effected outcomes both for the overall study sample, as well as those under and over 55 years at randomization. For each analysis, there will identify between four options: the dietary pattern reduced recurrence and mortality; it reduced recurrence but not mortality; it did not reduce recurrence but reduced mortality and it had no effect on either recurrence or mortality. The study will also investigate relationships between different components of the dietary pattern, circulating carotenoids and study endpoints.