TRIAL/VITAMIN E BETA CAROTENE & ASPIRIN IN WOMEN

我们建议进行随机、双盲、安慰剂对照、2x2 β-胡萝卜素和维生素E作为化学避孕剂的析因试验 在减少因以下原因而患肺癌的高危女性中的发病率 他们吸烟的时间很长。由于设计上的原因，我们还可以 独立评估这两种药物潜在的化学预防作用 微量营养素对乳腺癌发病率的影响。这场审判将会进行 在大约19,000名美国女护士中，年龄在40岁至74岁之间， 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以下问题的问卷 过去的病史，饮食，癌症的危险因素，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 收到包含安慰剂的日历包，为期三个月的“磨合” 句号。这一策略将用来排除糟糕的编译人员，因此 增加试验检测小到中等影响的能力。 符合治疗方案和试验指南的参与者 在磨合期内，仍有意愿和资格的人将 随机分配接受β-胡萝卜素(50 mg，q.o.d)或 安慰剂。为了保持高依从性，药片将被包装在 方便，一个月的日历包，这样每个参与者都可以 每天只吃一片。每隔六个月，我们将邮寄日历包 以及询问合规性的问卷，任何一方 影响，以及终点的发生率。终端将通过以下方式进行确认 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，证明了高依从性和 近期参加本院护理工作的抽样调查结果分析 完成了为期两年的试点研究，以及从 我们对护士的大规模队列研究，我们相信这项试验将提供 这两种微量营养素在初级营养素中每一种的最终测试 预防中老年两种主要癌症 女人。

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.