S0000D: A Study of the Effect of Vitamin E and/or Selenium on Adenomatous Colorectal Polyps (ACP) in Participants Enrolled in SELECT
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 8,094
- 试验地点
- 1
- 主要终点
- Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo
研究概览
简要总结
RATIONALE: Studying tissue samples in the laboratory from participants receiving treatment on the Selenium and Vitamin E Cancer Prevention Trial (SELECT) SWOG-S0000 may help doctors predict a participant's response to treatment and help plan the best treatment.
PURPOSE: This phase III trial is studying the effect of vitamin E and/or selenium on colorectal polyps in men enrolled on SELECT Trial SWOG-S0000.
详细描述
OBJECTIVES:
Primary
- To assess the effect of selenium on colorectal adenoma (CRA) occurrence.
- To assess the effect of selenium on number, location, size, histologic type, and degree of dysplasia of CRA.
- To assess the effect of selenium on colorectal cancer (CRC) incidence.
Secondary
- To assess the effect of vitamin E on CRA occurrence.
- To assess the effect of vitamin E on CRC incidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 120 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vitamin E + selenium placebo
Vitamin E and selenium placebo daily for 7 - 12 years
干预措施: Vitamin E (Drug)
Vitamin E + selenium placebo
Vitamin E and selenium placebo daily for 7 - 12 years
干预措施: selenium placebo (Drug)
Selenium + vitamin E placebo
Selenium and vitamin E placebo daily for 7 - 12 years
干预措施: Selenium (Drug)
Selenium + vitamin E placebo
Selenium and vitamin E placebo daily for 7 - 12 years
干预措施: Vitamin E placebo (Drug)
Vitamin E + selenium
Vitamin E and selenium daily for 7 - 12 years
干预措施: Vitamin E (Drug)
Vitamin E + selenium
Vitamin E and selenium daily for 7 - 12 years
干预措施: Selenium (Drug)
Vitamin E placebo + selenium placebo
Vitamin E placebo and selenium placebo daily for 7 - 12 years
干预措施: Vitamin E placebo (Drug)
Vitamin E placebo + selenium placebo
Vitamin E placebo and selenium placebo daily for 7 - 12 years
干预措施: selenium placebo (Drug)
结局指标
主要结局
Effect of Selenium on Advanced Neoplasia, Analyzed by Active Selenium vs. Selenium Placebo
时间窗: From 1 year post randomization through study completion
Adenomas with diameter \>=1cm or any adenoma with villous features or high-grade dysplasia
Effect of Selenium and/or Vitamin E on Colorectal Cancer (CRC) Incidence
时间窗: From 1 year post randomization through study completion
Effect of Selenium on Colorectal Adenoma (CRA) Occurrence, Analyzed by Active Selenium vs. Selenium Placebo
时间窗: From 1 year post randomization through study completion
Effect of Selenium on Occurrences of Multiple (>2) Adenomas
时间窗: From 1 year post randomization through study completion
次要结局
- Effect of Vitamin E on CRA Occurrence, Analyzed by Active Vitamin E vs. Vitamin E Placebo(From 1 year post randomization through study completion)