ALPHA-TOCOPHEROL, BETA-CAROTENE LUNG CANCER PREVENTION STUDY

α-生育酚、β-胡萝卜素预防肺癌的研究

• 批准号: 5201375
• 负责人: D ALBANES
• 金额: --
• 依托单位: DIVISION OF CANCER PREVENTION AND CONTROL
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5201375
• 关键词: Scandinavian country; cancer prevention; carcinogenesis inhibitor; carotene; chemoprevention; clinical trials; drug screening /evaluation; human subject; human therapy evaluation; longitudinal human study; lung neoplasms; male; medical complication; neoplasm /cancer epidemiology; neoplasm /cancer nutrition therapy; nutrition aspect of cancer; nutrition related tag; questionnaires; tobacco abuse; tocopherols; vitamin therapy

The Alpha-Tocopherol, Beta-Carotene Lung Cancer Prevention Study (ATBC Study) is investigating the efficacy of daily oral alpha-tocopherol (50 mg) and beta-carotene (20 mg) in a double-blind, randomized 2x2 factorial design trial aimed at preventing lung cancer among 50-69 year old male cigarette smokers. The project is based on experimental and epidemiological research which demonstrates a potential preventive role for these agents. Recruitment took place between 1985-88, and the trial intervention ended on schedule March 31, 1993 after an average followup of over 6 years. A postal survey screening for potential trial participant was sent to 291,000 men in southern Finland, and 76% responded. We invited the smokers willing to participate (43,000) to one of 13 study clinics, and over 29,000 were randomized into the study. Compliance to the one capsule daily regimen has remained very high (97% average), and the dropout rate averages less than 6% per year. Reduction of lung cancer incidence in the active agent groups is the primary study goal; differences in the occurrence of other cancers will also be evaluated. Several pilot studies in support of the trial have also been completed including a feasibility study, validation of study dietary questionnaires, and evaluation of skin yellowing and serum levels following beta- carotene administration. This trial is being conducted collaboratively with the Surveillance Program and the Biometry Branch of the Division of Cancer Prevention and Control and with the National Public Health Institute of Finland.

α-生育酚、β-胡萝卜素预防肺癌的研究 (ATBC研究）正在研究每日口服α-生育酚的疗效 (50 mg）和β-胡萝卜素（20 mg）在一项双盲、随机2x2 预防50-69岁人群肺癌的析因设计试验 吸烟的老男人 该项目是基于实验和 流行病学研究表明潜在的预防作用 对于这些代理商。 招募发生在1985年至1988年之间， 在平均随访后，干预于1993年3月31日按计划结束 超过6年。 筛选潜在试验参与者的邮寄调查 发给芬兰南部的291，000名男性，76%的人做出了回应。 我们 邀请愿意参加的吸烟者（43，000人）参加13项研究之一 超过29，000人被随机分配到研究中。 符合 每天一粒胶囊的方案仍然很高（平均97%）， 辍学率平均每年不到6%。 肺复位术 活性药物组的癌症发病率是主要研究目标; 还将评估其他癌症发生率的差异。 此外，当局亦已完成多项试验研究，以配合这项试验计划 包括可行性研究，验证研究饮食问卷， 和评估皮肤变黄和血清水平， 胡萝卜素给药。 这项试验是与监督合作进行的。 计划和癌症预防司生物统计学分支 与芬兰国家公共卫生研究所合作。