RCT OF PLANT-BASED DIET IN BREAST CANCER RECURRENCE

描述(申请人描述)：来自生态的证据， 流行病学和实验室研究一直支持 认为饮食消费的总体模式可以提供 预防乳腺癌及其复发的保护作用。这 保护模式的特点是每天消耗大量的 蔬菜、水果和纤维的能量消耗水平较低 胖的。在乳腺癌确诊后引入这样的饮食可能会 将复发率降低30%-40%。在预赛中 随机可行性研究我们已经证明乳腺癌 幸存者可以通过电话咨询计划来激励他们 习惯于这种包括5种蔬菜的日常饮食模式 一份，16盎司蔬菜汁，3个水果，30克纤维和 消耗的能量中有15%-20%来自脂肪。用大学的礼物钱， 我们已经开始了一项多中心随机对照试验，以测试 采用和维持这种饮食是否可以减少糖尿病的复发 来自加利福尼亚州、亚利桑那州选定地区的乳腺癌幸存者， 还有德克萨斯州。600多名女性被随机抽出了一个目标 3,000人在确诊为I期后4年内(大于或 等于1厘米)，II期和IIIA期疾病并已完成 常规疗法。到目前为止，我们已经证明我们能够 89%的人保持对饮食模式的充分坚持 完成这项研究12个月而只有8%的女性 对照组术中均有粘连。我们通过以下方式验证合规性 循环中的类胡萝卜素和雌激素生物标志物。参与者为 每6个月联系一次，以进行健康状况评估和体检 所有报告的癌症或死亡的记录都会被审查。为了获得 深入了解饮食可能如何影响疾病的机制，我们 将比较循环中的类胡萝卜素和雌激素水平 有继发性癌症事件，其水平与匹配的一组女性 没有复发。此外，我们正在收集和储存巴菲 涂层以及肿瘤标本，以供未来相关研究之用。如果我们的 研究小组的预测与最近发表的女性相似 研究表明，我们将有超过0.90的能力来检测16%的 在研究期间乳腺癌事件的改善。不管怎样 饮食干预的结果，这项研究的结果 将对未来乳房研究的方向产生重大影响 癌症控制。

DESCRIPTION (Applicant's Description): Evidence from ecological, epidemiological and laboratory studies consistently supports the contention that an overall pattern of dietary consumption can provide a protective effect against breast cancer and its recurrence. This protective pattern is characterized by a high daily consumption of vegetables, fruits and fiber with low levels of energy consumed from fat. The introduction of such a diet after breast cancer diagnosis may reduce the recurrence rate by 30-40 percent. In a preliminary randomized feasibility study we have demonstrated that breast cancer survivors can be motivated through a telephone counseling program to habituate to such daily dietary pattern that includes 5 Vegetable servings, 16 ounces of vegetable juice, 3 fruits, 30 grams of fiber with 15-20 percent of energy consumed from fat. With University gift monies, we have started a multicenter randomized controlled trial to test whether the adoption and maintenance of this diet reduces recurrence in breast cancer survivors from selected regions of California, Arizona, and Texas. More than 600 women have been randomized out of a target of 3,000 who are within 4 years of diagnosis of stage I (greater than or equal to 1 cm), stage II and stage IIIA disease and who have completed conventional therapy. To date we have demonstrated that we are able to maintain adequate adherence to the dietary pattern in 89 percent of women who have completed 12 months on this study while only 8 percent of the control group were adherent. WE validate adherence with circulating carotenoid and estrogen biomarkers. Participants are contacted every 6 months for a health status assessment and medical records are reviewed for all reported cancers or deaths. To gain insight into the mechanism of how diet might influence the disease, we will compare circulating carotenoid and estrogen levels in women who have a secondary cancer event with levels in matched set of women who have not recurred. In addition, we are collecting and storing buffy coat as well as tumor specimens for future correlative studies. If our study groups have prognoses similar to women in recently published studies, we will have greater than 0.90 power to detect a 16 percent improvement in the breast cancer events in the study period. Regardless of the outcome of the dietary intervention, the results of this study will have major implications for future directions of research in breast cancer control.