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

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ClinicalTrials.gov Identifier: NCT01477866
Recruitment Status : Suspended (the study has never started)
First Posted : November 23, 2011
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Manfredi Rizzo, University of Palermo

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 2 years ]


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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • stage IIIa-IIIc (AJCC/TNM)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Manfredi Rizzo, Assistant Professor, University of Palermo
ClinicalTrials.gov Identifier: NCT01477866     History of Changes
Other Study ID Numbers: CITOGENEX CRC
First Posted: November 23, 2011    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017

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