Curcumin Chemoprevention of Colorectal Neoplasia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Gene expression
研究概览
简要总结
Colorectal cancer is a major problem in the United States and other developed countries. A safe and effective chemopreventive agent could reduce the burden of colorectal neoplasia. Curcumin, is a product that is derived from Curcuma longa. It has been used for thousands of years as a traditional remedy. Curcumin blocks a number of targets involved in tumor initiation, promotion, and progression, and is considered a promising chemopreventive agent. The investigators propose to enroll 40 patients after screening colonoscopy who will have rectal biopsies at baseline and after 4 weeks of curcumin 4 grams per day. The investigators will use microarray analysis to identify genes that are modified by curcumin that could be used as biomarkers in future chemoprevention studies. The study will also evaluate tolerability and toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A willingness to follow the study protocol, as indicated by provision of informed consent to participate
- •Good general health
排除标准
- •Familial colorectal cancer syndromes (e.g. Hereditary Non-Polyposis Colon Cancer, Familial Adenomatous Polyposis)
- •Ulcerative colitis or Crohn's disease.
- •History of large bowel resection for any reason
- •Diagnosed narcotic or alcohol dependence
- •Unwillingness to forgo curcumin/turmeric-containing supplements during the trial or consumption of curry/turmeric at meals > 3 times a week.
- •Allergy to turmeric/curcumin.
- •Women with childbearing potential who do not agree to practice effective birth control.
- •Individuals with creatinine, AST or ALT above 1.5 times the upper limit of normal at baseline.
- •Personal or inherited bleeding disorders or therapeutic anti-coagulation with warfarin.
- •Women who are pregnant or nursing.
- •Individuals who have taken antibiotics within the three months prior to enrollment.
研究组 & 干预措施
Curcumin
4g Curcumin C3 tablet daily
干预措施: Curcumin C3 tablet (Drug)
结局指标
主要结局
Gene expression
时间窗: 30 days
Change in gene expression
Ribonucleic acid (RNA) level
时间窗: 30 days
Transcript level as mRNA copies per cell
Apoptosis
时间窗: 30 days
Immunohistochemistry (IHC) signal as intensity and proportion of cells stained
次要结局
- Number of Participants with Adverse Events(30 days)