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

临床试验：湾区女性健康饮食和生活试验

• 批准号: 7717842
• 负责人: Marcia L Stefanick
• 金额: $ 0.01万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-12-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7717842
• 关键词: American; Antioxidants; Area; California; Calories; Cancer Center; Cancer Survivor; Cereals; Characteristics; Class; Clinical; Clinical Research; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Control Groups; Counseling; Diagnosis; Diet; Dietitian; Disease; Disease regression; Eating; Edible Plants; End Point; Enrollment; Estrogens; Event; Fatty acid glycerol esters; Fiber; Fruit; Funding; Goals; Grant; Guidelines; Institution; Instruction; Intervention; Juice; Life; Living Wills; Localized; Malignant Neoplasms; Medical; National Cancer Institute; Nutrient; Participant; Phytochemical; Plasma; Randomized Controlled Clinical Trials; Recurrence; Research; Research Personnel; Resources; Risk; Second Primary Cancers; Source; Staging; Telephone; Testing; United States National Institutes of Health; Vegetables; Woman; cooking; day; follow-up; fruits and vegetables; insight; malignant breast neoplasm; oncology; programs

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 有证据表明，如果目前美国人的饮食指南明显富含可食用植物和纤维，并减少脂肪含量，那么在疾病得到诊断和常规治疗后，局部乳腺癌的消退和进展可能会减少30-50%。 妇女健康饮食和生活（WHEL）研究是一项为期6年的多中心随机试验，共有3,104名癌症幸存者参加，比较了接受国家癌症研究所（NCI）饮食指南指导的效果，即<30%的卡路里来自脂肪，= 5份/天的水果和蔬菜，= 6份/天的谷物，并有一个饮食咨询计划，其中有以下饮食目标：15-20%的卡路里来自总脂肪，= 30克纤维/天，= 5份蔬菜加上16盎司/天的蔬菜汁，重点是“营养丰富”的蔬菜，即具有高含量的抗氧化剂和特定植物化学物质的那些，并且= 3份/天的水果。 WHEL研究参与者在诊断为I期（>1 cm）、II期和IIIA期疾病的4年内，并已完成常规治疗。 北方加州癌症中心是六个临床中心之一，招募了517名妇女，其中355人正在斯坦福大学GCRC接受测试和随访。 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，这些课程由注册营养师指导，他们也提供临时咨询。 医学随访是按照常规肿瘤学实践进行的，以确定无病生存期和总生存期的临床研究终点。 WHEL将确定6岁时饮食干预组与NCI饮食对照组相比，复发风险是否可以降低20%。为了深入了解饮食如何影响疾病的机制，WHEL将患有继发性癌症事件的女性的血浆类胡萝卜素和内源性雌激素水平与癌症尚未复发的女性的水平进行比较，但研究组和对照组的其他特征相匹配。