Phase III Study of the Effects of Selenium on Adenomatous Polyp Recurrence
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 1,621
- 试验地点
- 7
- 主要终点
- Number of Recurrent Adenomas at Surveillance Colonoscopy
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Selenium may be effective in preventing the recurrence of adenomatous colorectal polyps.
PURPOSE: This randomized phase III trial is studying selenium to see how well it works in preventing the recurrence of polyps in patients with adenomatous colorectal polyps.
详细描述
OBJECTIVES:
Primary
- Compare the effects of selenium vs placebo on the recurrence of adenomatous colorectal polyps, in terms of histologic type, degree of dysplasia, number, size, and location, in patients with adenomatous colorectal polyps.
- Compare the type, incidence, and outcome of side effects in patients treated with these regimens.
- Determine patient adherence to long-term treatment with these regimens.
Secondary
- Determine the effects of regimen modification by baseline blood selenium level, low-dose aspirin, selenoprotein genetic marker polymorphisms (e.g., GPx-1, GPx-2, and SEP15)
- Determine the effects of low-dose aspirin (81 mg/day) modification by ornithine decarboxylase promoter genotype, and toxicity by slow-metabolizer genotypes of the cytochrome p450 2C9 and UT1A6 loci in these patients.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 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
Selenium
Participants receive oral selenium 200 mcg once daily.
干预措施: Selenium (Drug)
Placebo
Participants receive oral placebo once daily.
干预措施: Selenium (Drug)
结局指标
主要结局
Number of Recurrent Adenomas at Surveillance Colonoscopy
时间窗: 3 to 5 years after baseline colonoscopy
Detection of metachronous colorectal adenomas during follow-up, by treatment, in the original cohort. Surveillance colonoscopy is recommended 3 to 5 years after removal of colorectal adenoma(s). Participants will remain on the study intervention until their surveillance colonoscopy. Surveillance colonoscopy is determined by participants' GI physician.
Median Selenium Blood Levels at One Year.
时间窗: One year
Adequate adherence to long-term selenium treatment as measured by blood selenium levels (ng/mL) at one year.
次要结局
未报告次要终点