Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- All cause mortality
研究概览
简要总结
The main aim of the present study is to test the efficacy and safety of CITOGENEX administration in patients with colon-rectal cancer.
详细描述
CITOGENEX is a dietary supplement of insoluble polysaccharides, of Lactobacillus Casei (specific type) and of Bifidobacterium Lactis (specific type). These subspecies of probiotics bacteria have been shown to be effective in improving the immunity. Several trials are currently underway, in order to evaluate the effects of probiotics as potential novel therapies in addition to traditional therapeutic approaches. Although probiotics do not play an anti-tumor action per se, these agents may significantly contribute to decrease the typical side effects due to traditional anti-tumor treatments, such as gastrointestinal symptoms, immunity deficit, as well as the alterations in the gut lymphoid tissue.
It is therefore expected that CITOGENEX may have several significant beneficial effects in patients under anti-tumor treatments. In order to test this hypothesis, we will perform a randomized, single-blind, two-arms, prospective study in patients with colon-rectal cancer.
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 (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stage IIIa-IIIc (AJCC/TNM)
排除标准
- 未提供
研究组 & 干预措施
citogenex
citogenex + conventional therapy
干预措施: citogenex (Dietary Supplement)
citogenex
citogenex + conventional therapy
干预措施: conventional therapy (Other)
conventional therapy
conventional therapy
干预措施: conventional therapy (Other)
结局指标
主要结局
All cause mortality
时间窗: 2 years
次要结局
未报告次要终点
研究者
Manfredi Rizzo
Assistant Professor
University of Palermo
