LOW FAT DIET AND BREAST CANCER RECURRENCE--OUTCOME TRIAL

妇女干预营养研究是一项前瞻性的， 一项随机、多中心的临床试验， 减少膳食脂肪摄入作为辅助治疗标准乳腺癌 治疗将减少疾病复发并增加 患有局限性乳腺癌的女性这个假设是基于 强有力的流行病学观察和合理的中介 作用机制，包括膳食脂肪对以下方面的影响： 循环类固醇激素，前列腺素合成，免疫 功能、调控基因表达和癌细胞膜 结构和功能。女性（>48至78岁）， 组织学诊断局限性乳腺癌 低脂肪饮食是可能的。 在适当的初级 治疗手术+/-放疗），所有患者均接受定义的全身性 辅助治疗（包括他莫昔芬、AC、CMF、FAC）。患者 被随机分配到两个饮食组中的一个作为唯一的 治疗变量;强化干预（IIG）或非 强化干预组（NIG）。 IIG接受个性化 和团体计划，以减少饮食脂肪摄入量的15%的热量。 NIG在现行的美国膳食指南中得到指导（30% 脂肪的热量）。两个饮食组的患者均接受咨询 关于RDA营养素的膳食充足性。膳食脂肪摄取 估计有一系列未经宣布的食品召回。重量变化 并且，在血清亚组中，脂肪酸浓度曲线评估 坚持饮食所有患者均随访无病生存期 (as主要研究终点）和总生存期。这多- 纪律，多中心试验包括一个行政单位， 外部咨询委员会、a营养协调股、a 统计协调股、两个区域营养中心和 超过30个参与临床研究中心的质量控制政策， 程序已经到位并在运作。最初两年的融资 结果显示， 乳腺癌患者的持续增加率， 饮食依从性足以明确地解决研究 假说.这项研究的成功完成将提供一个 减少膳食脂肪摄入量对 乳腺癌患者结局。

The Women's intervention Nutrition Study (WINS) is a prospective, randomized, multi-center clinical trial testing the hupothesis that dietary fat intake reduction as an adjuvant ti standard breast cancer therapy will reduce disease recurrence and increase survival for women with localized breast cancer. The hypothesis is based on strong epidemiological observations and plausible mediating mechanisms of action which include dietary fat influence on: circulating steroid hormones, prostaglandin synthesis, immune function, regulatory gene expression, and cancer cell membrane structure and function. Women (>48 to 78 vears of age) with a histologic diagnosis of localized breast cancer not already consuming a low-fat diet are potentially eligible. Following appropriate primary therapy surgery +/- radiation), all patients receive defined systemic adjuvant therapy (including tamoxifen, AC, CMF, FAC). Patients are randomly assigned to one of two Dietary Groups as the sole treatment variable; either Intensive Intervention (IIG) or Non- Intensive Intervention (NIG) Groups. The IIG receive individualized and group programs to reduce dietary fat intake to 15% of calories. The NIG are instructed in the current U.S. Dietary Guidelines (30% of calories from fat). Patients in both Dietary Groups are counselled regarding the dietary adequacy for RDA nutrients. Dietary fat intake is estimated with serial, unannounced food recalls. Weight change and, in a subset-serum, fatty acid concentration profiles assess dietary adherence. All patients are followed for disease-free survival (as primary study endpoint) and overall survival. This multi- disciplinary, multi-center trial includes an Administrative Unit, an External Advisory Committee, a Nutritional Coordinating Unit, a Statistical Coordinating Unit, two Regional nutrition Centers and over 30 participating Clinical Sites Quality control policies and procedures are in place and operative. The initial two years funding of the WINS outcome Trial has demonstrated an ability to maintain a sustained rate of breast cancer patient accrual with associated dietary adherence sufficient to definitively address the study hypothesis. The successful completion of this study will provide a definitive evaluation of the effect of dietary fat intake reduction on breast cancer patient outcome.