NCT00973869Unknown1 期
A Pilot Study of Administration of Curcumin to Determine Colonic Curcumin Tissue Levels in Patients Awaiting Colorectal Endoscopy or Patients With Colorectal Cancer Awaiting Resection
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Concentration of curcumin in colorectal tissue after treatment
研究概览
简要总结
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of curcumin may prevent or treat colorectal cancer.
PURPOSE: This phase I trial is studying the side effects of curcumin in preventing colorectal cancer in patients undergoing colorectal endoscopy or colorectal surgery.
详细描述
OBJECTIVES:
Primary
- To determine levels of curcumin and its metabolites in normal colorectal tissue in patients undergoing colorectal endoscopy or colorectal cancer surgery following a 14-day course of curcumin.
Secondary
- To assess the practicality, acceptability, and safety of administering 5 capsules of curcumin daily for 14 days.
- To check the presence of curcumin and its metabolites in peripheral blood and urine.
研究设计
- 研究类型
- Interventional
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Meets 1 of the following criteria:
- •Has a positive fecal occult blood test found during a pilot colorectal cancer screening program
- •Awaiting diagnostic or surveillance colonoscopy
- •Diagnosis of colorectal cancer
- •PATIENT CHARACTERISTICS:
- •Able to return for follow-up tests
- •Fertile patients must use effective contraception
- •No discrete gastric or duodenal ulcer > 5 mm in the past year
- •Patients with a history of Helicobacter pylori-related peptic ulcer disease are eligible after successfully completing antibiotic treatment for Helicobacter pylori
- •No significant medical or psychiatric problem, including significant renal, hepatic, or hematological dysfunction, that would make the patient a poor candidate for this study
- •PRIOR CONCURRENT THERAPY:
- •More than 3 months since prior investigational agents
- •No prior pelvic radiotherapy
- •No other concurrent investigational agents
排除标准
- 未提供
结局指标
主要结局
Concentration of curcumin in colorectal tissue after treatment
次要结局
- Tolerability and compliance
- Presence of curcumin and its metabolites in peripheral blood and urine
研究者
研究点 (2)
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