PREVENTION OF NON-MELANOMA SKIN CANCER SUPPLEMENT

预防非黑色素瘤皮肤癌补充剂

• 批准号: 3194010
• 负责人: LARRY C CLARK
• 金额: $ 15.54万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 1988
• 资助国家: 美国
• 起止时间: 1988-08-15 至 1993-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3194010
• 关键词: cancer prevention; clinical trials; dietary supplements; human subject; neoplasm /cancer diagnosis; neoplasm /cancer epidemiology; neoplasm /cancer nutrition therapy; nutrition related tag; questionnaires; selenium; skin neoplasms

This study is a double blind randomized clinical trial prevention of basal cell epithelioma and squamous cell of carcinoma of the skin with a nutritional supplement of selenium. The treatment is 200 mcg of selenium as a selenium enriched brewer's yeast, the placebo is an identical tablet of brewer's yeast. This dose and form of Se has been approved for use in this trial by the food and drug Administration since it is a commercially available product. In the study which preceeds this application over 241 patients have been randomized with no observed toxic effects from treatment. The treatment group has shown a good response to the selenium supplement with their initial plasma levels of Se rising from .12 mcg/ml at the 6 month and at the 12 month examination. This clinical trial has been preceded by a case control and cohort study which demonstrated an increase risk of non-melanoma skin cancer (NMSC) among patients with low plasma selenium levels. These two epidemiologic studies and the current trial provide the justification and experience necessary to conduct this trial. Based on these two epidemiologic studies we predict that a .1 mcg/ml rise in plasma Se levels should be associated with a 50% reduction in the ratio of time to new NMSC if the patients are followed for a sufficient, but unknown period of time. This study is designed to detect a 26% reduction in the ratio of time to new NMSC during the minimum 3.5 years of treatment and follow-up. This study will provide the critical test of the hypothesis that improving selenium status can reduce the risk of cancer.

本研究是一项双盲随机临床试验， 细胞上皮瘤和鳞状细胞癌的皮肤， 硒的营养补充。治疗是200微克的硒， 一种富含硒的啤酒酵母，安慰剂是一种相同的片剂， 啤酒酵母该剂量和形式的Se已被批准用于本发明。 由于这是一个商业上的试验， 可用的产品。 在本申请之前的研究中， 随机分组，未观察到治疗的毒性作用。治疗 小组对硒补充剂表现出良好的反应， 硒的初始血浆水平从6个月时的.12 mcg/ml上升到 12个月检查 本临床试验之前进行了病例对照和队列研究 这表明，非黑素瘤皮肤癌（NMSC）的风险增加， 血浆硒水平低的患者。这两项流行病学研究 和目前的审判提供了必要的理由和经验， 进行这次审判。根据这两项流行病学研究，我们预测， 血浆硒水平升高0.1 mcg/ml应与50%的 如果对患者进行随访， 一个足够的时间，但未知的时间。这项研究旨在检测 在至少3.5年内，新NMSC的时间比减少26% 治疗和随访。这项研究将提供关键的测试， 改善硒状况可以降低癌症风险的假说。