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

U

University of Palermo

Status

Suspended

Conditions

Colonic Neoplasms

Treatments

Other: conventional therapy
Dietary Supplement: citogenex

Study type

Interventional

Funder types

Other

Identifiers

NCT01477866
CITOGENEX CRC

Details and patient eligibility

About

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

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

40 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • stage IIIa-IIIc (AJCC/TNM)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

250 participants in 2 patient groups

citogenex
Experimental group
Description:
citogenex + conventional therapy
Treatment:
Other: conventional therapy
Dietary Supplement: citogenex
conventional therapy
Active Comparator group
Description:
conventional therapy
Treatment:
Other: conventional therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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