Evaluation of the Efficacy of a Combination of Micronutrients (Vitamin A, C, E, Selenium and Zinc) in Reducing the Incidence of Colorectal Metachronous Adenomas. A Double Blind, Phase III, Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 411
- 试验地点
- 1
- 主要终点
- occurrence of metachronous adenomas or cancer detected during endoscopic follow up examinations
研究概览
简要总结
The trial was aimed at evaluating the efficacy of a multiagent antioxidant compound (vitamin A, C, E, selenium and zinc) in reducing the incidence of metachronous adenomas of the large bowel after endoscopic polypectomy. This is a randomized study: a 50% reduction in the incidence of metachronous adenomas was expected in patients allocated to the "active" compound (intervention) arm as compared to those assigned to a placebo.
详细描述
Adenomatous polyps (or adenoma) are benign lesions of the large bowel that are frequent in people aged 60 or more: about one in four of them has at least one adenoma. In time, adenoma could progress to cancer. Even though only a small rate of adenomas will develop into cancer almost 70-80% of colorectal cancer origin from an adenoma and colorectal cancer is one of the most frequent malignant tumors in the western world. Several epidemiological studies showed that subjects who had low intake and/or low blood levels of selenium were at increased risk of developing colorectal cancer.
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 25-75 years
- •at least one histologically confirmed adenoma endoscopically removed from the large bowel resulting in a polyp-free colon-rectum (clean colon).
排除标准
- •polypectomy performed more than 6 months before enrolment in the trial
- •history of Familial Adenomatous Polyposis
- •inflammatory bowel disease
- •adenoma with invasive carcinoma
- •ten or more adenomas
- •large sessile adenoma (3 cm or more
- •colorectal resection
- •invasive cancer at any site
- •life-threatening and/or chronic heart, liver or kidney diseases
- •current use of vitamin or calcium supplements
- •mental disability
研究组 & 干预措施
antioxidants
tablets composed of 200 mcg selenium [as l-selenomethionine], 30 mg zinc, 2 mg vitamin A [retinol], 180 mg vitamin C [ascorbic acid] and 30 mg vitamin E [D-α-tocopherol acetate]
干预措施: antioxidants (Drug)
Sugar pill
placebo had an identical appearance as intervention
干预措施: placebo (Drug)
结局指标
主要结局
occurrence of metachronous adenomas or cancer detected during endoscopic follow up examinations
时间窗: five years
次要结局
未报告次要终点
研究者
Luigina Bonelli
MD, responsible of the unit of secondary prevention and screening
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy