Curcumin for Treatment of Intestinal Adenomas in Familial Adenomatous Polyposis (FAP)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Polyp Number
研究概览
简要总结
This randomized phase II trial studies curcumin in treating patients with familial adenomatous polyposis. Curcumin may prevent colorectal cancer in patients with a history of rectal polyps or colorectal neoplasia.
详细描述
Specific Aims:
I. To determine in a randomized, double-blinded, placebo-controlled study the tolerability and effectiveness of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in familial adenomatous polyposis patients with intact colons, ileorectal anastomosis surgery, or ileo-anal pullthrough (reservoir) surgery.
II. To measure markers of cell proliferation including colorectal mucosal levels of ornithine decarboxylase (ODC), polyamines, mucosal deoxyribonucleic acid (DNA) methylation, proliferative index (Ki67 antiproliferative cell nuclear antibody), apoptosis index, vascular density, mucosal prostaglandin, leukotriene levels, and activation of the nuclear factor kappa B (NFKB), and v-akt murine thymoma viral oncogene homolog 1 (Akt) survival pathways.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive curcumin orally (PO) twice daily (BID) for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total colectomy with ileo-anal pull through (reservoir), and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or reservoir
- •Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis without current lower tract adenomatous polyposis i.e. status/post (s/p) ileostomy
排除标准
- •Female patients of childbearing age not on effective birth control
- •Pregnant women
- •White blood cell count (WBC) < 3500/ml
- •Platelet count < 100,000/ml
- •Blood urea nitrogen (BUN) > 25mg%
- •Creatinine > 1.5mg%
- •Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs), aspirin, curcumin, tumeric, calcium, vitamin D, green tea, or polyphenol E supplements for the duration of the trial
- •Malignancy other than nonmelanoma skin cancer
- •Active bacterial infection
- •Patients with symptoms of active gastroesophageal reflux disease (GERD) (symptomatic despite medication or current erosive esophagitis on endoscopy)
- •Patients with a history of peptic ulcer disease
- •Patients on warfarin or plavix
研究组 & 干预措施
Arm I (curcumin)
Patients receive curcumin PO BID for 12 months. Laboratory Biomarker Analysis
干预措施: Curcumin (Drug)
Arm I (curcumin)
Patients receive curcumin PO BID for 12 months. Laboratory Biomarker Analysis
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (placebo)
Patients receive placebo PO BID for 12 months. Laboratory Biomarker Analysis
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (placebo)
Patients receive placebo PO BID for 12 months. Laboratory Biomarker Analysis
干预措施: Placebo (Other)
结局指标
主要结局
Polyp Number
时间窗: Up to 12 months
Average number of polyps in the placebo arm at the end of the study is compared to the average in the curcumin arm
次要结局
- Mean Polyp Size in mm(Up to 12 months)
- Number of Participants With a Decrease in Polyp Burden at 12 Months(12 months)
- Medication Compliance(Up to 12 months)
- Change in Ornithine Decarboxylase (ODC) Activity Levels(Baseline and 8 months)
- Change in Total Polyamines Levels(Baseline and 8 months)
- Change in Micro RNA 124-U6 (miR124-U6)(Baseline and 8 months)
- Change in Spermine Oxidase (SMOX)(Baseline and 8months)
- Change in Spermidine/Spermine N-1 Acetyl Transferase (SSAT)(Baseline and 8 months)
- Number of Participants With Grade >=2 Adverse Events(Up to 12 months)
- Change in Ki-67 Anti-proliferative Cell Nuclear Antibody Index Levels(Baseline up to 8 months)
- Change in Apoptosis Index Levels(8 months)