CITOGENEX PA: Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer

Sponsor

University of Palermo (Other)

Overall Status

Suspended

CT.gov ID

NCT01477866

Collaborator

(none)

250

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

The main aim of the present study is to test the efficacy and safety of CITOGENEX administration in patients with colon-rectal cancer.

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms	Dietary Supplement: citogenex Other: conventional therapy	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer

Arms and Interventions

Arm	Intervention/Treatment
Experimental: citogenex citogenex + conventional therapy	Dietary Supplement: citogenex CITOGENEX is a dietary supplement of insoluble polysaccharides, of Lactobacillus Casei (specific type) and of Bifidobacterium Lactis (specific type). Other: conventional therapy conventional therapy for colon-rectal cancer
Active Comparator: conventional therapy conventional therapy	Other: conventional therapy conventional therapy for colon-rectal cancer

Arm

Intervention/Treatment

Experimental: citogenex

citogenex + conventional therapy

Dietary Supplement: citogenex

CITOGENEX is a dietary supplement of insoluble polysaccharides, of Lactobacillus Casei (specific type) and of Bifidobacterium Lactis (specific type).

Other: conventional therapy

conventional therapy for colon-rectal cancer

Active Comparator: conventional therapy

conventional therapy

Other: conventional therapy

conventional therapy for colon-rectal cancer

Outcome Measures

Primary Outcome Measures

All cause mortality [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

stage IIIa-IIIc (AJCC/TNM)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Palermo	Palermo	PA	Italy	90129

Sponsors and Collaborators

University of Palermo

Investigators

Study Director: Giovanni Tomasello, MD, University of Palermo
Study Chair: Francesco Cappello, MD, University of Palermo
Principal Investigator: Provvidenza Damiani, MD, University of Palermo
Principal Investigator: Manfredi Rizzo, MD, University of Palermo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Manfredi Rizzo, Assistant Professor, University of Palermo

ClinicalTrials.gov Identifier:

NCT01477866

Other Study ID Numbers:

CITOGENEX CRC

First Posted:

Nov 23, 2011

Last Update Posted:

Dec 12, 2017

Last Verified:

Dec 1, 2017

Additional relevant MeSH terms:

Colonic Neoplasms

Study Results

No Results Posted as of Dec 12, 2017