Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer

NCT ID: NCT01477866

Last Updated: 2017-12-12

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL

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.

Conditions

Colonic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

citogenex

citogenex + conventional therapy

Group Type: EXPERIMENTAL

citogenex

Intervention Type: DIETARY_SUPPLEMENT

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

conventional therapy

Intervention Type: OTHER

conventional therapy for colon-rectal cancer

conventional therapy

conventional therapy

Group Type: ACTIVE_COMPARATOR

conventional therapy

Intervention Type: OTHER

conventional therapy for colon-rectal cancer

Interventions

citogenex

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

Intervention Type: DIETARY_SUPPLEMENT

conventional therapy

conventional therapy for colon-rectal cancer

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• stage IIIa-IIIc (AJCC/TNM)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Palermo

OTHER

Sponsor Role: lead

Responsible Party

Manfredi Rizzo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giovanni Tomasello, MD

Role: STUDY_DIRECTOR

University of Palermo

Francesco Cappello, MD

Role: STUDY_CHAIR

University of Palermo

Provvidenza Damiani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Palermo

Manfredi Rizzo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Palermo

Locations

University of Palermo

Palermo, PA, Italy

Countries

Italy

Other Identifiers

CITOGENEX CRC

Identifier Type: -

Identifier Source: org_study_id