TRIAL/VITAMIN E BETA CAROTENE & ASPIRIN IN WOMEN

试用/维生素E β-胡萝卜素

• 批准号: 2092813
• 负责人: Julie E. Buring
• 金额: $ 228.61万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-02-01 至 1996-09-05
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2092813
• 关键词: breast neoplasms; cancer prevention; cancer risk; carotene; chemoprevention; clinical trials; dosage; drug screening /evaluation; female; human middle age (35-64); human old age (65+); human subject; longitudinal human study; lung neoplasms; neoplasm /cancer epidemiology; nutrition aspect of cancer; nutrition related tag; therapy compliance; tobacco abuse; tocopherols

We propose to conduct a randomized, double-blind, placebo-controlled, 2x2 factorial trial of beta-carotene and vitamin E as chemoprophylactic agents in reducing the incidence of lung cancer among women at high risk due to their long duration of cigarette smoking. Due to the design, we can also independently assess the potential chemopreventive role of these two micronutrients on incidence of breast cancer. This trial will be conducted among approximately 19,000 female U.S. nurses, 40-74 years of age, with a total current or past duration of cigarette smoking of at least 15 years. We will send a description of the trial and questionnaires inquiring about past medical history, diet, risk factors for cancer, and possible contraindications to beta-carotene and vitamin E to approximately 1.3 million potential participants. The nurses who agree to participate will be sent calendar packs containing placebos for a three-month "run-in" period. This strategy will serve to exclude poor compliers, thus increasing the power of the trial to detect small to moderate effects. Participants who comply with the treatment regimen and the trial guidelines during the run-in period and who remain willing and eligible, will be assigned at random to receiving either beta-carotene (50 mg q.o.d.) or placebo. To maintain high compliance, pills will be packaged in convenient, one-month calendar packs, so that each participant will take only one pill per day. At six-month intervals we will mail calendar packs and questionnaires asking about compliance, the occurrence of any side effects, and the incidence of endpoints. Endpoints will be confirmed by review of medical records. Based upon our successful experience with the ongoing Physicians Health Study, the demonstrated high compliance and follow-up of the sample of nurses who participated in our recently completed two-year pilot study, as well as the long-term experience from our large cohort study of nurses, we believe this trial will provide definitive tests of each of these two micronutrients in the primary prevention of the two leading types of cancer among middle-aged and older women.

我们建议进行一项随机、双盲、安慰剂对照、2x2 β-胡萝卜素和维生素 E 作为化学预防剂的析因试验 降低因以下原因导致的高危女性肺癌发病率 他们长期吸烟。 由于设计的原因，我们还可以 独立评估这两种药物的潜在化学预防作用 微量营养素对乳腺癌发病率的影响。 本次试验将进行 大约 19,000 名 40-74 岁的美国女护士中， 当前或过去吸烟的总持续时间至少为 15 年。 我们将发送试验说明和询问问卷 既往病史、饮食、癌症危险因素以及可能的 β-胡萝卜素和维生素 E 的禁忌症约为 1.3 百万潜在参与者。 同意参加的护士将 发送包含安慰剂的日历包以进行为期三个月的“磨合” 时期。 该策略将有助于排除不良合规者，从而 增加试验的力量以发现小到中度的影响。 遵守治疗方案和试验指南的参与者 在磨合期内并且仍然愿意且符合资格的人将 随机分配接受 β-胡萝卜素（每日 50 毫克）或 安慰剂。 为了保持高依从性，药丸将包装在 方便的一个月日历包，让每个参与者都能 每天只需一粒药。 我们将每隔六个月邮寄日历包 以及询问遵守情况、任何一方发生情况的调查问卷 影响和终点的发生率。 端点将被确认 审查医疗记录。 根据我们的成功经验 正在进行的医生健康研究，表现出高度的依从性和 对最近参加我们的护士样本的跟踪 完成了两年的试点研究，以及长期的经验 我们对护士进行的大型队列研究，我们相信这项试验将提供 对初级食品中这两种微量营养素的确定性测试 中老年人两大癌症的预防 女性。