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

Primary Purpose

Colonic Neoplasms

Status

Suspended

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

citogenex

conventional therapy

About this trial

This is an interventional treatment trial for Colonic Neoplasms

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

stage IIIa-IIIc (AJCC/TNM)

Sites / Locations

University of Palermo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

citogenex

conventional therapy

Arm Description

citogenex + conventional therapy

conventional therapy

Outcomes

Primary Outcome Measures

All cause mortality

Secondary Outcome Measures

Full Information

NCT ID

NCT01477866

First Posted

November 18, 2011

Last Updated

December 9, 2017

Sponsor

University of Palermo

1. Study Identification

Unique Protocol Identification Number

NCT01477866

Brief Title

Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer

Acronym

CITOGENEX PA

Official Title

Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Suspended

Why Stopped

the study has never started

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Palermo

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colonic Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

citogenex

Arm Type

Experimental

Arm Description

citogenex + conventional therapy

Arm Title

conventional therapy

Arm Type

Active Comparator

Arm Description

conventional therapy

Intervention Type

Dietary Supplement

Intervention Name(s)

citogenex

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

conventional therapy

Intervention Description

conventional therapy for colon-rectal cancer

Primary Outcome Measure Information:

Title

All cause mortality

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: stage IIIa-IIIc (AJCC/TNM)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giovanni Tomasello, MD

Organizational Affiliation

University of Palermo

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Francesco Cappello, MD

Organizational Affiliation

University of Palermo

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Provvidenza Damiani, MD

Organizational Affiliation

University of Palermo

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Manfredi Rizzo, MD

Organizational Affiliation

University of Palermo

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Palermo

City

Palermo

State/Province

ZIP/Postal Code

90129

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer

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