PREVENTION OF NON-MELANOMA SKIN CANCER

本研究是一项双盲随机临床试验，预防基础 皮肤癌的细胞上皮瘤和鳞状细胞瘤 硒的营养补充剂。治疗剂量为200mgSe。 一种富硒啤酒酵母，安慰剂是一种相同的片剂 酿酒酵母。这种剂量和形式的硒已被批准用于 由食品和药物管理局进行试验，因为这是一种商业 可用的产品。 在这项应用之前的研究中，已经有241名患者被 随机化，没有观察到治疗的毒性作用。治疗方法 小组对补硒表现出良好的反应，他们的 最初的血浆硒水平在6个月时从0.12微克/毫升上升到 12个月检查。 这项临床试验之前进行了病例对照和队列研究。 这表明非黑色素瘤皮肤癌(NMSC)的风险增加 血浆硒水平低的患者。这两项流行病学研究 目前的审判提供了必要的理由和经验 进行这场审判。根据这两项流行病学研究，我们预测 1.1微克/毫升血浆硒水平升高应与50% 如果对患者进行跟踪治疗，减少新的NMSC的时间比率 充足但未知的一段时间。这项研究旨在检测 在至少3.5年内减少26%的时间与新NMSC的比率 治疗和随访方面的问题。这项研究将提供关键的测试 假设改善硒状况可以降低患癌症的风险。

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.