NCT00033319Unknown不适用
UKCAP Trial: A Multi-Center Double Blind Randomised Controlled Trial Of Aspirin And/Or Folate Supplementation For the Prevention Of Recurrent Colorectal Adenomas
Queen's Medical Center62 个研究点 分布在 1 个国家开始时间: 1997年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 试验地点
- 62
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. The use of aspirin and/or folic acid may be effective in preventing recurrent polyps in patients who have had polyps removed previously.
PURPOSE: Randomized clinical trial to determine the effectiveness of aspirin and/or folic acid in preventing the recurrence of colorectal polyps.
详细描述
OBJECTIVES:
- Determine whether aspirin and/or folic acid prevents recurrence of colorectal adenomas in patients who have had colorectal adenomas removed.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive oral aspirin and oral folic acid daily.
- Arm II: Patients receive oral aspirin and oral placebo daily.
- Arm III: Patients receive oral placebo and oral folic acid daily.
- Arm IV: Patients receive 2 oral placebos daily. In all arms, treatment continues for 3 years in the absence of unacceptable toxicity.
After completion of the 3-year intervention, all patients undergo a surveillance colonoscopy.
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed colorectal adenoma removed within the past 6 months
- •Greater than 0.5 cm after fixation or greater than 0.7 cm at time of removal
- •Any size with a history of prior colorectal adenoma removal(s)
- •Removed via colonoscopy, flexi-sigmoidoscopy (provided barium enema has been performed), or transanal endoscopic microsurgery
- •Removal must be considered complete with follow-up to be done within 6 months
- •No prior resection of large bowel (e.g., hemi-colectomy or greater, anterior resection, or subtotal colectomy)
- •PATIENT CHARACTERISTICS:
- •75 and under
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •No active bleeding disorders
- •Not specified
- •Not specified
- •Cardiovascular:
- •No unstable heart conditions
- •No unstable asthma
- •Not pregnant and no potential to become pregnant within the next 3 years
- •No unstable diabetes
- •No active upper gastrointestinal ulceration
- •No known aspirin intolerance or sensitivity
- •No other serious medical conditions that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •See Disease Characteristics
- •No other concurrent folic acid
- •No concurrent anticoagulants
- •No other prior or concurrent non-steroidal anti-inflammatory drugs, prescribed or self-medicated (more than 3 tablets per week)
排除标准
- 未提供
研究者
研究点 (62)
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