Chemoprevention of Esophageal Squamous Cell Carcinoma With Aspirin and Tea Polyphenols: a Randomized Controlled Trial.
试验速览
- 阶段
- 3 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- occurrence of high grade dysplasia and invasive ESCC
研究概览
简要总结
Evidence from laboratory studies suggests that aspirin and tea polyphenols may have an antineoplastic effect in esophageal squamous cell carcinoma (ESCC). To assess the safety and efficacy of aspirin and tea polyphenols for preventing ESCC, the investigators designed this double-blind, randomized controlled clinical trial. Research project is planned to recruit 10,000 participants with the ages of 40-60 years in Fengfeng city, Hebei province, China, which has been known as a high incidence region of ESCC. All the participants receive endoscopic examination. Lugol's chromoendoscopy is used to identify esophageal unstained lesions (USLs). The location and size of each USL will be recorded followed by collecting biopsy samples from each USL. Participants with USL are randomly assigned to receive 100 mg/d of aspirin (n=200), 100 mg/d of tea polyphenols (n=200), or placebo (n=200) for six months. Follow-up consists of 2 endoscopic surveillance cycles (the first interval will be at six months and the second at 3 or 5 years later). The primary outcome measure was occurrence of high grade dysplasia and invasive ESCC. Secondary outcome was the mortality of the participants and adverse events.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 40 to 60 years;
- •Lugol's chromoendoscopy showing at least one USL 1 cm or larger containing mild to moderate dysplasia and chronic inflammation;
- •subject neither pregnant nor intending to become pregnant during the study.
排除标准
- •current non-steroidal anti-inflammatory drugs (NSAID) therapy;
- •major intercurrent illness;
- •invasive carcinoma;
- •any condition that could be worsened by aspirin or tea polyphenols.
研究组 & 干预措施
Aspirin
干预措施: Aspirin (Drug)
Tea Polyphenols
干预措施: Tea Polyphenols (Dietary Supplement)
结局指标
主要结局
occurrence of high grade dysplasia and invasive ESCC
时间窗: at six months
次要结局
- the mortality of the participants(The first interval will be at six months and the second at 3 or 5 years later.)
- Number of participants with adverse events.(The first interval will be at six months and the second at 3 or 5 years later.)
- occurrence of high grade dysplasia and invasive ESCC(at 3 or 5 years later)
研究者
Shu-Tian Zhang
Professor
Beijing Friendship Hospital