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Phase IIA Chemopreventative Study of Selenium in Persons at Risk for Lung Cancer

机译：肺癌危险人群中硒的IIa期化学预防研究

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Selenized yeast has also recently been shown to reduce lung cancer incidence and mortality in a population of skin cancer patients. Smokers and survivors of early stage lung and head and neck cancers have had a long period of promotion by carcinogenic agents on the bronchial epithelium resulting in morphologic and molecular alterations. We hypothesize that these morphologic and molecular alterations can be detected and modulated by chemopreventive agents. We have proposed a Phase lla chemoprevention trial evaluating five different dose levels of selenium administered daily for 3 months in subjects at high risk for lung cancer with bronchoscopically documented dysplasia. Subjects will be entered to determine the effect of dose on the modulation of biomarkers in response to selenium supplementation as well as to measure selenium levels and modulation of glutathione peroxidase as a measure of drug effect. In addition to morphology, the surrogate endpoint biomarkers to be examined include apoptosis, p53 expression, K-ras mutation analysis, p16 methylation, and upregulation of hnRNP A2/B1. Successful completion of this study will support selenium supplementation as potentially beneficial therapy in preventing the progression of lung carcinogenesis as well as identify surrogate endpoint markers that appear to be modulated by selenium supplementation.

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