LOW FAT DIET--WOMEN AT INCREASED RISK FOR BREAST CANCER

这建议在国家癌症研究所建立和运作一个临床单位， 低钙饮食疗效的多中心随机临床试验 脂肪（20%的热量）在预防乳腺癌的妇女， 增加患乳腺癌的风险。 试验的主要目的是 确定低脂饮食是否可以降低乳腺癌的发病率。 本申请建议该股参与所有三个阶段的 通过合作协议机制进行的试验： 两个月的方案，十个月的可行性试验， 为期48个月的全面试验。 贝勒临床单位将包括 贝勒脂质研究诊所与美国国家卫生研究院合作， 圣约瑟夫医院乳腺癌检测中心 为 可行性和全面试验，该股将研究一个队列的200-240 从乳腺癌检测中心招募的患者， 方案标准。 该单位将与审判的其他单位合作， 临床单位、营养协调单位、统计协调单位、 和国家癌症研究所 贝勒股的主要目标包括：1）经营 使用微型计算机辅助的经济和准确的临床单元 监督和管理诊所业务和质量控制 数据 2)为了获得本疗效试验的最大饮食依从性， 标准和创新技术的结合，包括选择 通过依从性筛选具有高依从性潜力的受试者 检查和洗脱标准，由受过培训的 营养师/依从性顾问接受咨询技巧培训 贝勒脂质研究诊所通过立即分析 用微机营养分析法记录病人7天的饮食情况 系统和多媒体教学的食物模型，烹饪示范， 幻灯片、时事通讯和公告板。 坚持咨询是 基于对依从性的识别、诊断和管理 问题使用行为技术和频繁的咨询师-病人 contact. 3)评价饮食记录、24小时饮食回忆、 1-7日常饮食自我记录，以及饮食依从性的客观测量， 体重、皮褶厚度、血浆总胆固醇和HDL 胆固醇和亚油酸在血浆胆固醇的比例 酯盐酸盐的褪 临床试验操作的最佳方法、依从性 管理和监督，从可行性试验将适用于 全面的试验。 该项目的意义在于， 制定预防高危妇女癌症的饮食方法 乳腺癌

This proposes to establish and operate a Clinical Unit in the NCI's Multicenter randominized clinical trial of the efficacy of a diet low in fat (20% of calories) in the prevention of breast cancer in women with increased risk for breast cancer. The trial's primary objective is to determine if the low-fat diet can decrease the incidence of breast cancer. This application proposes the unit's participation in all three phases of the Trial by the cooperative agreement mechanism: development of the protocol in two months, the feasibility trial of ten months, and the full-scale trial of 48 months. The Baylor Clinical Unit will consist of the Baylor Lipid Research Clinic working in collaboration by subcontract with the Breast Cancer Detection Center of St. Joseph's Hospital. For the feasibility and full scale trials, the Unit will study a cohort of 200-240 patients recruited from the Breast Cancer Detection Center according to the protocols criteria. The unit will collaborate with the Trial's other Clinical Units, Nutrition Coordinating Unit, Statistical Coordinating Unit, and the NCI. The Baylor Unit's major aims include: 1) To operate the Clinic Unit with economy and accuracy using a micro-computer assisted surveillance and management of clinic operations and quality control of data. 2) To gain maximum dietary adherence for this efficacy trial using a combination of standard and innovative techniques, including selection of subjects with high potential for adherence by an adherence screening examination and washout criteria, individual counseling by trained Dietitian/Adherence Counselors trained in counseling techniques developed by the Baylor Lipid Research Clinic aided by immediate analysis of the patient's 7-day food record by the micro-computer based Nutrient Analysis System and multimedia instruction by food models, cooking demonstrations, slide tapes, newsletters, and bulletin boards. Adherence counseling is based upon the identification, diagnosis of and management of adherence problems using behavioral techniques and frequent counselor-patient contact. 3) To evaluate methods of diet recording, 24-hour diet recall, 1-7 day diet self-recording, and objective measures of diet adherence as body weight, skin fold thickness, plasma total cholesterol, and HDL cholesterol, and the proportion of linoleic acid in the plasma cholesteryl esters. The optimum methods of clinical trial operation, adherence management and surveillance, from the feasibility trial will be applied to the full-scale trial. The project's significance is a potential for developing a dietary method for prevention of cancer in women at high-risk of breast cancer.