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

This study has suspended participant recruitment.
(because Study Chair and Director have not yet submitted it to Ethic Committee)
Sponsor:
Information provided by (Responsible Party):
Manfredi Rizzo, University of Palermo
ClinicalTrials.gov Identifier:
NCT01477866
First received: November 18, 2011
Last updated: October 25, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention
Colonic Neoplasms
Dietary Supplement: citogenex
Other: conventional therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer

Resource links provided by NLM:


Further study details as provided by University of Palermo:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stage IIIa-IIIc (AJCC/TNM)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477866

Locations
Italy
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
  More Information

No publications provided

Responsible Party: Manfredi Rizzo, Assistant Professor, University of Palermo
ClinicalTrials.gov Identifier: NCT01477866     History of Changes
Other Study ID Numbers: CITOGENEX CRC
Study First Received: November 18, 2011
Last Updated: October 25, 2012
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 22, 2014