RCT OF PLANT-BASED DIET IN BREAST CANCER RECURRENCE

描述(由申请人提供)：这项建议是为了完成和结束妇女健康饮食和生活(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，检验以植物为基础的饮食模式会影响额外的乳腺癌事件和死亡率的假设。这项研究招募了3109名妇女，她们在最初诊断为I期(1厘米)、II期和IIIA期乳腺癌的4年内完成了标准治疗。这项研究使用了行为改变理论驱动的全面和量身定制的干预措施，以激励干预组参与者大幅增加蔬菜、水果和纤维的日常摄入量，同时以一种应该导致循环中类胡萝卜素大幅增加的饮食模式减少脂肪。这项研究包括对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的定期测量，以及身体测量的记录，以及血浆、血清、黄褐色外套和洗过的红细胞样本的收集和存储。从原始肿瘤中储存了10张组织切片。每六个月联系所有参与者进行健康状况评估，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，并制定灵活的评估时间表，以减轻参与者的负担。在研究的第四年，我们评估补充和替代医学服务的使用情况。这项研究目前正在实现其所有目标。在基线时，每一组都报告每天消费大约三份蔬菜。在一年中，干预组每天报告的蔬菜/蔬菜汁摄入量为7.1份，对照组为3.1份；对于那些在研究中至少有两年的人，干预组每天蔬菜摄入量为6.4份，对照组为3.1份。循环中类胡萝卜素的持续变化是：A-胡萝卜素+89%干预-3%比较；[3-胡萝卜素水平+57%干预+叶黄素+23%干预+对照组+7%。这项研究将使用意向治疗分析来评估研究干预是否影响了整个研究样本以及55岁以下和55岁以上随机分组的结果。对于每一项分析，将确定四个选项：饮食模式减少复发和死亡率；它减少复发但不减少死亡率；它没有减少复发但降低死亡率，它对复发或死亡率都没有影响。这项研究还将调查饮食结构的不同成分、循环中的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.