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临床试验/NCT01477866
NCT01477866暂停不适用

Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer

University of Palermo2 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2011年11月23日最近更新:
适应症
干预措施

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

入选标准

  • stage IIIa-IIIc (AJCC/TNM)

排除标准

  • 未提供

研究组 & 干预措施

citogenex

Experimental

citogenex + conventional therapy

干预措施: citogenex (Dietary Supplement)

citogenex

Experimental

citogenex + conventional therapy

干预措施: conventional therapy (Other)

conventional therapy

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Manfredi Rizzo

Assistant Professor

University of Palermo

研究点 (2)

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