SWOG S0000: SELENIUM AND VITAMIN E CANCER PREVENTION TRIAL (SELECT)

SWOG S0000：硒和维生素 E 癌症预防试验（选择）

• 批准号: 7606603
• 负责人: ANNE R. SIMONEAU
• 金额: $ 2.17万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606603
• 关键词: African American; Age; Behavior; Cancer Prevention Trial; Caring; Caucasians; Caucasoid Race; Chemoprevention; Computer Retrieval of Information on Scientific Projects Database; Controlled Clinical Trials; Data; Development; Diet Habits; Disease; Funding; Grant; Institution; Intervention; L-Selenomethionine; Learning; Life; Malignant Neoplasms; Malignant neoplasm of prostate; Medical; Methods; Morbidity - disease rate; Numbers; Pattern; Phase III Clinical Trials; Placebo Control; Placebos; Primary Prevention; Prostate carcinoma; Purpose; Randomized; Rate; Research; Research Personnel; Resources; Risk; Role; Selenium; Selenium/vitamin E; Skin Carcinoma; Source; Staging; Testing; United States National Institutes of Health; Vitamin E; Vitamins; age related; alpha Tocopherol; base; carcinogenesis; design; lifetime risk; male; men; mortality; pill; prevent; tumor

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. Prostate cancer has been the most common malignant tumor (excluding non-melanoma skin cancer) in U.S. men for the last decade. It has been estimated that the lifetime risk of developing prostate cancer is 16.6% for Caucasian males and 18.1% for African-American males, and the overall prostate cancer mortality risk for men age 50 is 2.9% (Ries, et. al. 1998, Scher; et. al. 1995). An ideal method to reduce the mortality and morbidity of carcinoma of the prostate would be through primary prevention: either through a reduction in the number of life-threatening, clinically-evident cases or through a reduced age-dependent rate of development of the disease, i.e., the disease would become evident 5, 10, 15 years later than otherwise would occur. Although there is evidence that the development of this tumor may be related to dietary habits, problems in changing such patterns of behavior and the need for life-long intervention make such a preventative method difficult in practice (Mishina, et. al., 1985). The purpose of this study is to compare the effects of the study supplements. The supplements are selenium (L-selenomethionine), vitamin E (alpha-tocopherol), selenium plus vitamin E and placebo (a pill containing no active substances). We want to see whether the supplements, other than the placebo, can prevent or reduce the occurrance of prostate cancer. In both selenium and vitamin E, the strongest evidence for their potential roles in preventing prostate cancer comes from secondary findings of two randomized, placebo-controlled clinical trials. The development of these two supplements has arrived at the stage where a randomized, placebo-controlled intervention is needed to test the primary hypothesis regarding these supplements' prostate cancer chemoprevention effects (Taylor, Albanes, 1998). Data indicate that activities of selenium and vitamin E are complementary and that the two supplements act synergistically to inhibit carcinogenesis (Hoekstra, 1975; Medina, 1986; Thompson, 1994). This evidence makes the 2x2 factorial design for simultaneously testing both supplements a particularly attractive option for the confirmatory Phase III trial. No studies looking at the effect of using both selenium and vitamin E have been done. Based on past studies using other agents as well as the two supplements we are testing here, we believe that men may get an added benefit from using these two supplements together. The main purpose of this trial is to learn more about prostate cancers in healthy men that are found as part of regular medical care. We want to know whether the study supplements can prevent or decrease these cancers.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 过去十年来，前列腺癌一直是美国男性最常见的恶性肿瘤（不包括非黑色素瘤皮肤癌）。 据估计，白种人男性终生患前列腺癌的风险为 16.6%，非洲裔美国男性为 18.1%，50 岁男性的前列腺癌总体死亡风险为 2.9%（Ries 等人，1998 年；Scher 等人，1995 年）。 降低前列腺癌死亡率和发病率的理想方法是通过一级预防：要么通过减少危及生命的临床明显病例的数量，要么通过降低年龄依赖性的疾病发展速度，即，该疾病将比其他情况晚 5、10、15 年变得明显。 尽管有证据表明这种肿瘤的发生可能与饮食习惯有关，但改变这种行为模式的问题以及终生干预的需要使得这种预防方法在实践中变得困难（Mishina等人，1985）。 本研究的目的是比较研究补充剂的效果。 这些补充剂包括硒（L-硒代蛋氨酸）、维生素 E（α-生育酚）、硒加维生素 E 和安慰剂（不含活性物质的药丸）。 我们想看看除了安慰剂之外的补充剂是否可以预防或减少前列腺癌的发生。 对于硒和维生素 E，其预防前列腺癌潜在作用的最有力证据来自两项随机、安慰剂对照临床试验的次要发现。 这两种补充剂的开发已经达到了需要随机、安慰剂对照干预来测试有关这些补充剂的前列腺癌化学预防作用的主要假设的阶段（Taylor，Albanes，1998）。 数据表明，硒和维生素 E 的活性是互补的，并且两种补充剂具有协同作用，可抑制致癌作用（Hoekstra，1975；Medina，1986；Thompson，1994）。 这一证据使得同时测试两种补充剂的 2x2 因子设计成为验证性 III 期试验特别有吸引力的选择。 目前还没有研究同时使用硒和维生素 E 的效果。 根据过去使用其他药物以及我们在这里测试的两种补充剂的研究，我们相信男性可以通过同时使用这两种补充剂获得额外的好处。 该试验的主要目的是更多地了解健康男性中前列腺癌的情况，这些癌症是常规医疗护理的一部分。 我们想知道研究补充剂是否可以预防或减少这些癌症。