LOW FAT DIET AND BREAST CANCER RECURRENCE--OUTCOME TRIAL

这项拟议的前瞻性随机临床试验将测试 饮食中脂肪摄入减少作为乳腺癌辅助治疗假说 干预将减少疾病复发并提高患者存活率 用于绝经后局部疾病的妇女。 潜在机制 这种疗法的作用包括膳食脂肪对 循环类固醇激素浓度，前列腺素合成， 免疫功能、调节基因表达和癌细胞膜 结构和功能。 这项研究将进入共2,000后- 绝经期妇女（>50岁），组织学诊断为 局部乳腺癌（阶段I-IIIa）谁有膳食脂肪摄入量。 在基线评估时的卡路里。 初次手术治疗后， 所有患者将接受全身他莫昔芬治疗， 化疗（CMF或AC）。 化疗将前瞻性定义为 临床亚组使用统计学中心随机化 协调股。 患者将被随机分配至 强化干预组（IIG）或非强化干预组 （NIG）。 IIG将接受个性化的计划，以减少 膳食脂肪摄入量为15%的热量。 NIG将被指示在 1990年美国膳食指南（30%的卡路里来自脂肪）。 患者 两个饮食组都将接受关于营养充足性的咨询， 他们饮食中的RDA营养素。 将估计膳食脂肪摄入量 一系列未经宣布的食品召回 血清脂肪酸浓度 曲线和体重变化也将评估饮食依从性。 所有 作为主要研究，将对患者进行无病生存期随访 终点和总生存期。 这项多学科研究将 在多机构试验中涉及20个机构， 一个行政单位，一个营养协调单位，一个统计单位， 协调股，三个区域营养中心， 营养干预和参与的临床单位。 的 本研究的成功完成将提供一个明确的评价 减少饮食脂肪对乳腺癌患者预后的影响。

This proposed prospective randomized clinical trial will test the hypothesis that dietary fat intake reduction as an adjuvant breast cancer intervention will reduce disease recurrence and increase patient survival for post-menopausal women with localized disease. Potential mechanisms of action for this therapy include the influence of dietary fat on circulating steroid hormone concentrations, prostaglandin synthesis, immune function, regulatory gene expression, and cancer cell membrane structure and function. This study will enter a total of 2,000 post- menopausal women (>50 years of age) with a histologic diagnosis of localized breast cancer (stage I-IIIa) who have a dietary fat intake .25% of calories at baseline assessment. Following primary surgical therapy, all patients will receive systemic tamoxifen therapy with or without chemotherapy (CMF or AC). Chemotherapy will be prospectively defined for clinical subgroups utilizing a central randomization at the Statistical Coordinating Unit. Patients will be randomly assigned to either an intensive intervention group (IIG) or a non-intensive intervention group (NIG). The IIG will receive individualized programs targeted to reduce dietary fat intake to 15% of calories. The NIG will be instructed in the 1990 U.S. Dietary Guidelines (30% of calories from fat). Patients in both dietary groups will be counselled regarding the nutritional adequacy of their diets for RDA nutrients. Dietary fat intake will be estimated with serial unannounced food recalls. Serum fatty acid concentration profiles and weight change will also assess dietary adherence. All patients will be followed for disease-free survival as primary study endpoints and overall survival. This multidisciplinary study will involve 20 institutions in a multiinstitutional trial and will include an Administrative Unit, a Nutritional Coordinating Unit, a Statistical Coordinating Unit, three Regional Nutrition Centers to facilitate nutritional intervention, and participating Clinical Units. The successful completion of this study will provide a definitive evaluation of the effect of dietary fat reduction on breast cancer patient outcome.