LOW FAT DIET AND BREAST CANCER RECURRENCE--OUTCOME TRIAL

妇女干预营养研究(WINS)是一项前瞻性的研究， 测试假体的随机、多中心临床试验 饮食脂肪摄入量减少作为标准乳腺癌的佐剂 治疗将减少疾病复发并提高存活率 患有局限性乳腺癌的女性。这一假设是基于 强有力的流行病学观察和似是而非的调解 作用机制包括饮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、调控基因表达与癌细胞膜 结构和功能。年龄在48至78岁之间的女性 未发生乳腺癌的局限性乳腺癌的组织学诊断 低脂肪饮食可能是符合条件的。在适当的主节点之后 治疗手术+/-放射)，所有患者接受定义的全身性 辅助治疗(包括他莫昔芬、AC、CMF、FAC)。病人 被随机分配到两个饮食组中的一个作为唯一 治疗变量；强化干预(IIG)或非 强化干预(NIG)组。IIG接待个性化 以及团体计划，将膳食脂肪摄入量减少到卡路里的15%。 NIG按照美国现行饮食指南进行指导(30% 来自脂肪的卡路里)。两个节食组的患者都得到了咨询 关于RDA营养素的饮食充分性。膳食脂肪摄入量 估计是连环的，未经宣布的食品召回。重量变化 而且，在一个亚组血清中，脂肪酸浓度谱评估 饮食依从性。所有患者都接受了无病生存的随访。 (作为主要研究终点)和总体存活率。这个多- 纪律、多中心审判包括一个行政单位、一个 外部咨询委员会，营养协调股，a 统计协调股、两个区域营养中心和 30多个参与的临床站点质量控制政策和 程序已经到位并可操作。最初的两年资助 胜诉结果试验证明有能力维持 与乳腺癌相关的乳腺癌患者的持续生存率 饮食依从性足以最终解决这项研究 假设。这项研究的成功完成将提供一个 明确评估减少膳食脂肪摄入量对 乳腺癌患者的预后。

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.