A PHASE III TRIAL OF A LOW-FAT DIET AND BREAST CANCER

低脂饮食与乳腺癌的 III 期试验

• 批准号: 3548530
• 负责人: BERNARD FISHER
• 金额: $ 0.64万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1985
• 资助国家: 美国
• 起止时间: 1985-02-01 至 1990-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3548530
• 关键词: blood chemistry; breast neoplasms; cancer prevention; cancer risk; cooperative study; dietary lipid; female; human subject; human therapy evaluation; longitudinal human study; mammography; neoplasm /cancer nutrition therapy; nutrition education; nutrition related tag; therapy compliance

The proposed study will examine the effects of a low fat diet (approximately equal to 20% of calories) on the incidence of breast cancer in a population of women at high risk for breast cancer. Women identified by the Breast Cancer Diagnostic Center (BCDC) of the University of Pittsburgh to have approximately a 1% annual risk for breast cancer and who agree to enter the study, will be randomly assigned to a low fat diet group or a control group with no dietary intervention. The Nutrition Research Group of the Nutrition Division of the Department of Epidemiology in the Graduate School of Public Health at the University of Pittsburgh will perform a pre-randomization interview at the potential participant's home. This interview is designed to allow determination of eligibility based on motivation and ability to substantially change their eating pattern. Once this eligibility has been established, the potential participant will have a physical examination and initial nutritional assessment performed at the Breast Cancer Diagnostic Center. This will include Biochemical measures of nutritional parameters, anthropometric measures and a dietary assessment. A two month period of intense active intervention will be conducted on those patients randomized to the low fat diet group. This will include six home visits supplemented by group session to provide knowledge and the necessary skills to develop and maintain a low fat eating pattern. Follow-up will be conducted every three months at clinic visits and supplemented by group sessions. Compliance will be monitored by FRR scores and measures of lipids or lipoproteins. All patients will have yearly FRR scores and food records. Nutritional adequacy will be monitored and, if necessary, an active intervention to correct significant deficiencies will occur. Physical examination will be conducted on both groups at 6 month clinic visits. Instruction in self-breast examination will be given at each clinical visit. Yearly xeromammograms will be obtained in both control and low fat diet groups.

这项拟议中的研究将检查低脂饮食的影响 （约等于20%的热量）对乳腺癌发病率的影响 在乳腺癌高危女性人群中。 查明的妇女 乳腺癌诊断中心（BCDC）的大学 匹兹堡每年患乳腺癌的风险约为1%， 同意参加研究，将被随机分配到低脂饮食组 或者没有饮食干预的对照组。 营养研究 流行病学系营养处小组 匹兹堡大学公共卫生研究生院将 在潜在参与者家中进行随机化前访谈。 该面试旨在根据以下因素确定资格 动机和能力，以大大改变他们的饮食模式。 一旦确定了这一资格，潜在参与者将 进行体格检查和初步营养评估， 乳腺癌诊断中心 其中包括生化 营养参数的测量、人体测量和饮食 考核 为期两个月的密集积极干预将是 对那些随机分配到低脂饮食组的患者进行。 这 将包括六次家访，并辅以小组会议， 知识和必要的技能，以发展和保持低脂肪饮食 格局 将每三个月在诊所访视时进行一次随访 并辅以小组会议。 遵守情况将由FRR进行监测 脂质或脂蛋白的评分和测量。 所有患者将有 年度FRR评分和食物记录。 将监测营养充足情况 必要时，积极干预，纠正重大 会出现缺陷。 将对两人进行体格检查 6个月门诊访视。 自我乳房检查指导 将在每次临床访视时给予。 每年的干乳图将 在对照组和低脂饮食组中均获得。