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期乳腺癌患者联合化疗或 化学激素疗法 所有合格患者将接受以下治疗： CMF，ER+淋巴结患者也将接受他莫昔芬治疗。 拟议研究的主要目标是确定 患者将遵守计划的程度， 显著的饮食改变，包括饮食脂肪减少。 为了监测依从性，将比较患者之间的脂肪评分 随机分配接受低脂饮食干预， 那些饮食没有改变的人。 这项研究坚持一个低- 高脂肪饮食是一个关键的中间步骤， 一项全面的结果研究是否评估了饮食中添加 标准的乳腺癌治疗是合理的。 这项研究将与六个临床研究机构合作进行。 一个营养和统计协调中心。 期间 两年期间将累积300名患者。 个人 研究招募的受试者将被随机分配到一个强化班， 干预组（IIG）或非强化干预组 （NIG）。 那些被分配到IIG的患者将接受一步一步的- 每两周进行一次饮食咨询， 前8周，然后是6个月的访问。 在最后 干预4个月，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，和生化变量，饮食依从性将是 在基线、3个月、6个月和12个月时监测。 患者将 随访一年，并在18岁和24岁时评估依从性 个月 除了测量饮食依从性外， 本研究的目的是：1）识别一组行为 和社会心理变量，这些变量可以作为个体变量， 饮食变化的预测因子，2）监测脂肪酸， 胆固醇、甘油三酯、HDL和LDL，以确定 这些措施与食物记录措施的相关性， 变化，以及3）调查脂肪分数与 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.