Prevention Of Cancer By Intervention With Selenium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 3
研究概览
简要总结
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Selenium may be effective in preventing cancer. It is not yet known which dose of selenium may be most effective in preventing cancer.
PURPOSE: Randomized pilot study to determine the effectiveness of selenium in preventing cancer in healthy people.
详细描述
OBJECTIVES: I. Determine whether daily supplementation with selenium significantly reduces total cancer incidence and site-specific cancer incidence in the general population. II. Determine whether this regimen has a beneficial effect on mood.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are stratified according to age (60-64 vs 65-69 vs 70-74). Participants are randomized to one of four arms. Arm I: Participants receive oral placebo once daily. Arm II: Participants receive low-dose oral selenium once daily. Arm III: Participants receive moderate-dose oral selenium once daily. Arm IV: Participants receive high-dose oral selenium once daily. Treatment in all arms continues for up to 2 years in the absence of unacceptable side effects or diagnosis of cancer.
PROJECTED ACCRUAL: A total of 510 patients (170 per stratum) will be accrued for this study within 9-12 months.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS: Healthy men and women No prior diagnosis of cancer except non-melanoma skin cancer
- •PATIENT CHARACTERISTICS: Age: 60 to 74 Performance status: SWOG 0-1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No active liver disease No known abnormal liver function Renal: No active kidney disease No known abnormal kidney function Other: HIV negative No diminished mental capacity that would preclude study
- •PRIOR CONCURRENT THERAPY: No other concurrent selenium supplements (50 ug/day or more)
排除标准
- 未提供
研究组 & 干预措施
Selenium yeast 300 micrograms per day
300 micrograms per day
干预措施: selenium (Dietary Supplement)
Selenium yeast 200 micrograms per day
200 micrograms per day
干预措施: selenium (Dietary Supplement)
Selenium yeast 100 micrograms per day
100 micrograms per day
干预措施: selenium (Dietary Supplement)
Placebo
Selenium yeast
干预措施: selenium (Dietary Supplement)