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Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer

40 Years
60 Years
Not Enrolling
Colonic Neoplasms

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Trial Information

Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer

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.

Inclusion Criteria:

- stage IIIa-IIIc (AJCC/TNM)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

All cause mortality

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Giovanni Tomasello, MD

Investigator Role:

Study Director

Investigator Affiliation:

University of Palermo


Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:




Start Date:

January 2012

Completion Date:

December 2014

Related Keywords:

  • Colonic Neoplasms
  • Neoplasms
  • Rectal Neoplasms
  • Colonic Neoplasms
  • Colorectal Neoplasms