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

这项拟议的研究将检验低脂肪饮食的效果。 (大约相当于20%卡路里)对乳腺癌发病率的影响 在乳腺癌高危女性人群中。确认女性身份 由加州大学乳腺癌诊断中心(BCDC) 匹兹堡每年患乳腺癌的风险约为1%，世卫组织 同意进入研究，将被随机分配到低脂饮食组 或不进行饮食干预的对照组。营养学研究 北京市流行病学系营养科小组 匹兹堡大学公共卫生研究生院将 在潜在参与者的家中进行一次预随机访谈。 此面试旨在根据以下条件确定资格 有动力和能力从根本上改变他们的饮食模式。 一旦确定此资格，潜在参与者将 在以下地点进行身体检查和初步营养评估 乳腺癌诊断中心。这将包括生化 营养参数的测量、人体测量和饮食 评估。为期两个月的密集积极干预将是 对那些患者随机分为低脂饮食组。这 将包括六次家访，并辅以小组会议，以提供 养成和保持低脂肪饮食所需的知识和技能 图案。每三个月在诊所就诊时进行随访。 并辅之以小组会议。合规性将由FRR进行监控 脂类或脂蛋白的分数和量度。所有的病人都会有 每年的FRR分数和食物记录。将监测营养充分性 如有必要，还将进行积极干预，以纠正 缺陷将会出现。两人都将进行体检 两组患者均在6个月内就诊。乳房自我检查指导 将在每次临床就诊时给予。每年的干乳房X光检查将是 在对照组和低脂饮食组均可获得。

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.