NCT00118989终止不适用
Phase II Double Blind Placebo-Controlled Trial of Curcuminoids' Effect on Cellular Proliferation, Apoptosis and COX-2 Expression in the Colorectal Mucosa of Subjects With Recently Resected Sporadic Adenomatous Polyps
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Cellular proliferation and apoptosis in the colonic mucosa
研究概览
简要总结
Specific Aims:
- To determine if curcuminoids modulate cellular proliferation as measured by proliferating cell nuclear antigen (PCNA) in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps.
Hypothesis: Curcuminoids decrease cellular proliferation in the colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps.
- To determine if curcuminoids modulate apoptosis, as measured by TUNEL assay, in the colorectal mucosa of subjects with previously resected adenomatous colonic polyps.
Hypothesis: Curcuminoids increase apoptosis in colorectal mucosa of subjects with previously resected sporadic adenomatous colonic polyps.
- To determine if curcuminoids modulate COX-2 expression as measured by immunohistochemical assays in subjects with previously resected adenomatous colonic polyps
Hypothesis: Curcuminoids decrease colorectal mucosa COX-2 expression in subjects with previously resected sporadic adenomatous colonic polyps.
- To determine if curcuminoids modulate COX-2 activity as measured by urinary eicosanoids
Hypothesis: Curcuminoids decrease concentrations of urinary eicosanoids.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A diagnosis for colon/rectal polyp resection, polypectomy
- •Subjects must be able to have the capacity and must be willing to provide informed consent
- •Premenopausal women must be surgically incapable of childbearing or be using a medically acceptable method of contraception (oral contraceptives, diaphragms, condoms with spermicide, IUD, progesterone injection or implant) throughout the entire length of the study
- •Men should wear condoms during the duration of the study given the unknown effects of curcumin on sperm viability, fertility
排除标准
- •Previous or current history of colorectal cancer
- •Previous history of Familial Polyposis Syndromes
- •Previous history of inflammatory bowel disease
- •Previous surgery of the large bowel
- •Liver disease defined as AST and ALT>3x upper limit of normal
- •Known history of gallstones, biliary colic or serum bilirubin >2.0
- •Cardiac disease including myocardial infarction, congestive heart failure, arrhythmia
- •Renal disease defined as creatinine >1.5
- •Hematopoietic disease defined as WBC<4000, platelet count <100,000, hemoglobin<10.0 or coagulation or bleeding disorder
- •Significantly impaired gastrointestinal function or absorption
- •Peptic ulcer disease
- •Active infection including viral, bacterial, atypical or fungal infections of any organ system including HIV
- •Previous history of allergy to turmeric, Indian curries, aspirin or NSAIDs
- •Pregnant or lactating women
- •Dementia or other neurologic or psychiatric disease which may impede the ability to follow the protocol
- •Inability to swallow pills
- •Prior or concurrent therapy with any herbal or dietary supplement containing curcuminoids
- •Concurrent use of anticoagulants or antiplatelets including warfarin, clopidogrel
- •Prior or concurrent use of colorectal cancer chemopreventive agents including herbals: Sulindac or other NSAIDs, aspirin, COX-2 inhibitors, 5-aminosalicylate, folate, calcium, or their use within 14 days of enrollment
- •Concurrent use of immunosuppressants
研究组 & 干预措施
PLACEBO
Placebo Comparator
placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months
干预措施: Curcuminoids (Dietary Supplement)
Curcuminoids C3 Complex® to be taken orally via caps
Experimental
Curcuminoids C3 Complex® or placebo to be taken orally via capsule form in the dose of 4 grams daily for a duration of four months
干预措施: Curcuminoids (Dietary Supplement)
结局指标
主要结局
Cellular proliferation and apoptosis in the colonic mucosa
时间窗: 4 months
次要结局
- COX-2 expression and activity(4 months)
研究者
研究点 (1)
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