CLINICAL TRIAL: WOMEN'S HEALTHY EATING AND LIVING TRIAL IN THE BAY AREA

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 有证据表明，如果美国人目前的饮食指南显著增加了可食用植物和纤维，并降低了脂肪含量，那么在用传统方法诊断和治疗乳腺癌后，局部乳腺癌的消退和进展可能会减少30%-50%。女性健康饮食和生活(WHEL)研究是一项为期6年的多中心随机试验，涉及3104名癌症幸存者，正在比较接受国家癌症研究所(NCI)饮食指南指导的效果。30%的卡路里来自脂肪，=5份/天的水果和蔬菜，=6份/天的谷物，饮食咨询计划有以下饮食目标：15-20%的卡路里来自总脂肪，=30克/天的纤维，=5份蔬菜+16盎司/天的蔬菜汁，重点是“营养密集型”蔬菜，即那些含有大量抗氧化剂和特定植物化学物质的蔬菜，以及=3份/天的水果。研究参与者在被诊断为I期(1厘米)、II期和IIIA期疾病的4年内，并完成了常规治疗。北加州癌症中心是六个临床中心之一，招募了517名女性，其中355人正在接受检测，并在斯坦福GCRC接受跟踪。除了USCD协调中心工作人员的电话咨询外，参与者还参加GCRC的定期烹饪课程，课程由注册营养师指导，他们也提供临时咨询。医学随访是通过通常的肿瘤学实践来确定临床研究的无病和总存活率的终点。WHEL将确定在6年后，饮食干预组与NCI饮食对照组相比，复发风险是否可以降低20%。为了深入了解饮食可能如何影响疾病的机制，WHEL正在将发生继发性癌症事件的女性的血浆胡萝卜素和内源性雌激素水平与癌症尚未复发、但在研究组和对照组的其他特征匹配的女性的水平进行比较。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Evidence suggests that regression and progression of localized breast cancer, after the disease has been diagnosed and treated by conventional means, might be reduced by 30-50% if current dietary guidelines for Americans were enriched markedly for edible plants and fiber and had a reduced fat content. The Women's Healthy Eating and Living (WHEL) study, a 6-yr multicenter randomized trial of 3,104 cancer survivors, is comparing the effect of receiving instruction on the dietary guidelines of the National Cancer Institute (NCI), i.e. <30% of calories from fat, = 5 servings/day of fruits and vegetables, = 6 servings/day of grains with a dietary counseling program which has the following dietary goals: 15-20% of calories from total fat, = 30 gm of fiber/day, = 5 servings of vegetables plus 16 oz/day of vegetable juice, with an emphasis on "nutrient-dense" vegetables, i.e. those with a high content of antioxidants and specific phytochemicals, and = 3 servings/day of fruit. WHEL Study participants were within 4 yrs of their diagnosis of stage I (>1 cm), II, and IIIA disease and had completed conventional therapy. The Northern California Cancer Center, one of six clinical centers, enrolled 517 women, 355 of whom are being tested and followed at the Stanford GCRC. In addition to telephone counseling by USCD Coordinating Center staff, participants attend regular cooking classes at the GCRC, which are directed by registered dietitians who also provide interim counseling. Medical follow-up is by usual oncology practice to determine clinical study endpoints of disease-free and total survival. WHEL will determine if the risk of recurrence can be reduced in the diet-intervention group by 20%, versus the NCI-diet control group, at 6 yrs. To gain insight into mechanisms of how diet might influence the disease, WHEL is comparing plasma carotinoids and endogenous estrogen levels in women who have a secondary cancer event with levels in women whose cancers have not yet recurred, but who are matched for other characteristics from both the study and control groups.