LOW-FAT DIET IN STAGE II BREAST CANCER--RANDOMIZED STUDY

人口和病例对照研究表明 饮食在乳腺癌病因学中的作用。拟议的研究将审查 300名绝经后妇女坚持饮食改变计划 II期乳腺癌患者同时接受化疗或 化疗激素疗法。所有符合条件的患者都将得到 CMF，ER+结节的患者也将接受他莫昔芬治疗。 拟议研究的主要目标是确定 患者将在多大程度上遵守计划，包括 显著的饮食改变，包括饮食脂肪的减少。 为了监测依从性，将比较患者之间的FAT评分 随机分配接受低脂饮食干预和 那些饮食没有改变的人。这项关于依从性的研究- 脂肪饮食是努力确定 一项全面的结果研究是否评估饮食添加到 标准的乳腺癌治疗是合理的。 这项研究将与六家临床医院合作进行 和一个协调营养和统计中心。在.期间 为期两年的300名患者将应计。个人 被招募到学习中的人将被随机分配到一个 干预组(IIG)或非强化干预组 (NIG)。那些被分配到IIG的患者将得到逐步- 每两周进行一次饮食咨询的阶梯式行为方法 前8周，随后每月6次访问。在决赛中 4个月的干预，患者将接受饮食咨询 每隔一个月。利用4天食物记录，24小时电话 回忆起，和生化变量，饮食依从性将是 在基线、3个月、6个月和12个月进行监测。病人将会是 跟踪一年，遵守情况将在18岁和24岁时进行评估 月份。 除了饮食依从性的测量外，次要的 本研究的目标是：1)确定一组行为 以及可以作为个体使用的心理社会变量 饮食变化的预测因素，2)监测脂肪酸， 胆固醇、甘油三酯、高密度脂蛋白和低密度脂蛋白 这些指标与膳食食品记录指标的相关性研究 改变，以及3)调查肥胖分数和 其他可能影响依从性的饮食因素。

Population and case-control studies indicate the involvement of diet in breast cancer etiology. The proposed study will examine adherence to a dietary alteration program for 300 postmenopausal stage II breast cancer patient in conjunction with chemotherapy or chemohormonal therapy. All eligible patients will be treated with CMF, those patients with ER+ nodes will also receive tamoxifen. The primary objective of the proposed study is to determine the degree to which patient will adhere to the program involving significant dietary alteration including dietary fat reductions. To monitor adherence, fat scores will be compared between patient randomly assigned to receive the low-fat dietary intervention and those whose diet is not changed. This study of adherence to a low- fat diet is a critical intermediary step in the effort to determine whether a full scale outcome study evaluating dietary addition to standard breast cancer therapy is justified. The study will be carried out in collaboration with six clinical unit and a coordinating nutrition and statistical center. During a two year period 300 patient will be accrued. Individuals recruited into the study will be randomly assigned to an Intensive Intervention group (IIG) or a Nonintensive Intervention group (NIG). Those patients assigned to the IIG will receive a step-by- step behavioral approach to dietary counseling every two weeks for the first 8 weeks, followed by 6 monthly visits. During the final 4 months of intervention, patient will receive dietary counseling every other month. Utilizing 4-day food records, 24-hour telephone recall, and biochemical variables, dietary adherence will be monitored at baseline, 3, 6 and 12 months. Patients will be followed for one year and adherence will be assessed at 18 and 24 months. In addition to the measurement of dietary compliance, the secondary objectives of this research are: 1) to identify a set of behavioral and psychosocial variables which can be used as individual predictors of dietary change, 2) to monitor fatty acids, cholesterol, triglycerides, HDL and LDL to determine the correlation of these measures with food record measures of dietary change, and 3) to investigate associations between fat scores and other dietary factors which might affect adherence.