Phase I-II Study of Pomegranate Extract Formulations in Colorectal Cancer Patients: Metabolic and Gene Expression Profiling in Tumoral and Normal Colon Tissues
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Phenolics and derived metabolites in colon tissues, plasma and urine.
研究概览
简要总结
The most relevant pomegranate phenolics (ellagitannins and ellagic acid) are extensively metabolized by the human gut microbiota to yield a number of metabolites called urolithins (mainly Uro-A). Urolithins have been reported to regulate in vivo the expression of genes involved in inflammation and cancer. Our hypothesis is that urolithins can be detected in the human colon mucosa where these metabolites can exert anti-inflammatory and anti-cancer activities. After colonoscopy and diagnosis, colorectal cancer patients will consume capsules containing three different pomegranate extract formulations until surgery. The aims of this trial are:
- To evaluate the disposition of pomegranate phenolics and urolithins in tumoral and normal colon tissues.
- To evaluate gene expression profiling and protein markers in tumoral and normal colon tissues from these patients.
- To compare different pomegranate extract formulations on the above.
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
- Single (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
- 否
入选标准
- •Colorectal cancer diagnosis.
- •Surgery required.
- •WHO status: between 0 and
- •Hemoglobin >10 g/dL
- •ALT >2.5-fold above the normal value.
- •Serum Bilirubin >1.5-fold above the normal value.
- •Creatinine <140 micromol/L
排除标准
- •Patients who do not satisfy inclusion criteria and,
- •Active pectic ulcer.
- •Pregnancy or breastfeeding.
- •Alcoholism.
- •Chemotherapy or radiotherapy a month prior to recruitment.
- •Treatment with steroids or other anti-inflammatory drugs a week prior to recruitment.
结局指标
主要结局
Phenolics and derived metabolites in colon tissues, plasma and urine.
时间窗: Change from baseline at 15 days
Occurrence of phenolics and gut-microbiota derived metabolites in tumoral and colon tissues, urine and plasma.
Gene expression profiling in colon tissues
时间窗: Change from baseline at 15 days
Gene expression profile changes in tumoral and normal colon tissues
次要结局
- IGF-1 (insulin-like growth factor-1)(Change from baseline at 15 days)
- CEA (carcnoembryonic antigen)(Change from baseline at 15 days)
- Number of patients with adverse events as a measure of safety and tolerability(Change from baseline at 15 days)
- microRNA expression profiling in colon tissues(Change from baseline at 15 days)
研究者
Juan Carlos Espín de Gea
Full Research Professor
National Research Council, Spain