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DIETARY INTERVENTION PROTOCOL -- NSABP

DIETARY INTERVENTION PROTOCOL -- NSABP
饮食干预方案——NSABP
批准号:
3548428
负责人:
BERNARD FISHER
金额:
$1.01万
依托单位国家:
美国
项目类别:
财政年份:
1984
资助国家:
美国
项目状态:
已结题
起止时间:
1984-09-01 至 1986-04-30

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中文摘要
翻译
这项拟议的研究将检验20%脂肪饮食对疾病的影响。 II期乳腺癌患者的自由生存期和生存期 目前正在接受三种正在进行的国家外科辅助剂之一 乳腺癌和肠癌项目(NSABP)的辅助治疗方案在 匹兹堡大学。已完成至少12项课程的患者 几个月的协议辅助治疗并同意进入这项研究,将是 随机分为低脂饮食组和对照组。 饮食干预。营养学研究所营养学研究组 公共研究生院流行病学系 匹兹堡大学的健康将在最初的营养方面表现出色 对所有患者进行评估。这将包括生化指标 营养参数、人体测量和饮食评估。 随后将对这些人进行为期两个月的积极干预 随机分为低脂组。这将包括两个主场和两个小组 提供知识和必要技能的课程,以发展和维护 一种低脂肪的饮食模式。每四个月进行一次跟进,地点为 在家或在诊所就诊。合规性将通过FRR分数和 脂类或脂蛋白的量度。所有患者将有每年24小时的 食品召回。将监测营养充分性,如有必要,还将 将进行积极干预,以纠正重大缺陷。 乳腺癌或乳腺癌复发的随访检查和检测 其他原发癌症,将遵循NSABP的要求。
英文摘要
The proposed study will examine the effects of a 20% fat diet on disease free survival and survival in women with stage II breast cancer who are currently entered on one of three ongoing National Surgical Adjuvant Project for Breast & Bowel Cancers (NSABP) adjuvant therapy protocols at the University of Pittsburgh. Patients who have completed at least 12 months of protocol adjuvant therapy and agree to enter this study, will be randomly assigned to a low fat diet group or a control group with no dietary intervention. The Nutrition Research Group of the Nutrition Division of the Department of Epidemiology in the Graduate School of Public Health at the University of Pittsburgh will perform at Initial Nutritional Assessment on all patients. This will include biochemical measures of nutritional parameters, anthropometric measures and a dietary assessment. A two-month period of active intervention will then be conducted on those randomized to the low fat group. This will include two home and two group sessions to provide knowledge and necessary skills to develop and maintain a low fat eating pattern. Follow-up will be conducted every four months at home or in clinic visits. Compliance will be monitored by FRR scores and measures of lipids or lipoproteins. All patients will have yearly 24-hour food recalls. Nutritional adequacy will be monitored and if necessary an active intervention to correct significant deficiencies will occur. Follow-up examinations and testing for recurrences of breast cancer or additional primary cancers, will follow the requirements of the NSABP.
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CORRELATIVE LABORATORY AND INNOVATIVE CLINICAL TRIALS
CORRELATIVE LABORATORY AND INNOVATIVE CLINICAL TRIALS
A PHASE III TRIAL OF A LOW-FAT DIET AND BREAST CANCER
COOPERATIVE GROUP OUTREACH PROGRAM
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