SIDE EFFECTS IN CHEMOPREVENTION WITH BETA-CAROTENE AND RETINAL

该项目将继续密切监测副作用， 1985-1987年在西雅图入组的受试者依从性- 基于II期和IV期研究“肺癌的化学预防 吸烟者的维生素A/β-胡萝卜素”和“癌症预防 维生素A和β-胡萝卜素在职业接触者中的作用 到阿斯彭”。 两个高危人群被随机分配到 安慰剂或视黄醇/β-胡萝卜素，以评估招募、依从性 以及这些药物可能的副作用， 评估化学预防效果的全面试验。 后续行动 将包括每3个月一次的电话或诊所联系，以及 受试者根据指示发起的电话或访视，以评估症状 或身体检查结果与β-胡萝卜素/视黄醇一致 方面的影响. 实验室研究将每年重复一次。 因为边 疗效和依从性与治疗时间有关，我们 我建议密切监测这两项研究中入组的1700例受试者， 再学习5年。 长期副作用的定义 以及它们与粘附性、血清中 相关分析物、累积剂量和其他变量至关重要 任何大规模人口的发展和实施， 使用视黄醇和/或β-胡萝卜素的研究。 入组受试者 在这个试验中，将作为我们全面规模的先锋集团， 有效性试验允许更精简，成本效益方面 在试验中实施监测系统。

This project will continue the close monitoring of side effects and adherence of subjects enrolled during 1985-1987 in the Seattle- based phase II and phase IV studies "Chemoprevention of Lung Cancer with Retinoids/Beta-carotene in Smokers" and "Cancer Prevention with Retinol and Beta-carotene in Persons Occupationally Exposed to Asbestos". Two high-risk populations have been randomized to placebo or retinol/beta-carotene to evaluate recruitment, adherence and possible side effects of these agents in preparation for a full-scale trial to assess chemopreventive efficacy. Follow-up will consist of phone or clinic contacts every 3 months, plus subject-initiated calls or visits as indicated to assess symptoms or physical findings consistent with beta-carotene/retinol side effects. Laboratory studies will be repeated yearly. Because side effects and adherence are related to the duration of treatment, we propose to closely monitor the 1700 subjects enrolled in these two studies for an additional 5 years. Defining long-term side effects and their relationship to adherence, serum concentrations of relevant analytes, cumulative dose, and other variables is crucial to the development and implementation of any large-scale population studies using retinol and/or beta-carotene. The subjects enrolled in this trial will serve as a Vanguard Group for our full scale efficacy trial allowing for a more streamlined, cost-effective side effect monitoring system in that trial.