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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 有证据表明，如果当前针对美国人的饮食指南明显富集了可食用的植物和纤维，并且脂肪含量降低，则通过常规手段诊断和治疗该疾病后，局部乳腺癌的消退和进展可能会降低30-50％。 妇女的健康饮食和生活（Whel）研究是3,104个癌症幸存者的6码多中心随机试验，正在比较接受指导对国家癌症研究所（NCI）（NCI）饮食指南的影响，即脂肪中的卡路里的卡路里<30％的卡路里<30％的脂肪和饮食计划的饮食/日期= 6次饮食的建议：总脂肪的卡路里，= 30克/天的纤维，= 5份蔬菜加16盎司/天的蔬菜汁，重点是“营养密度”的蔬菜，即抗氧化剂和特定植物化学物质含量较高的蔬菜，以及= 3份水果/天/天。 研究参与者在诊断为I期（> 1 cm），II和IIIA疾病的4年内，并且已经完成了常规疗法。 北加州癌症中心是六个临床中心之一，招收了517名妇女，其中355名正在接受测试，并在斯坦福GCRC进行了测试。 除了USCD协调中心工作人员的电话咨询外，参与者还参加了GCRC的定期烹饪班，这是由还提供临时咨询的注册营养师指导的。 医学随访是按照通常的肿瘤学实践来确定无病和总生存的临床研究终点。 在6岁时，与NCI-DIET对照组相比，WHEL将确定在饮食干预组中是否可以将复发的风险降低20％。 为了深入了解饮食如何影响疾病的机制，Whel正在比较患有继发性癌症事件的女性血浆类胡萝卜素和内源性雌激素水平，其癌症尚未复发的女性水平，但与研究和对照组相匹配。