NCT01477866

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

First QC Date

November 18, 2011

Last Update Submit

December 9, 2017

Conditions

Colonic Neoplasms

Outcome Measures

Primary Outcomes (1)

  • All cause mortality

    2 years

Study Arms (2)

citogenex

EXPERIMENTAL

citogenex + conventional therapy

Dietary Supplement: citogenexOther: conventional therapy

conventional therapy

ACTIVE COMPARATOR

conventional therapy

Other: conventional therapy

Interventions

citogenexDIETARY_SUPPLEMENT

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

citogenex
conventional therapyOTHER

conventional therapy for colon-rectal cancer

citogenexconventional therapy

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • stage IIIa-IIIc (AJCC/TNM)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Palermo

Palermo, PA, 90129, Italy

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Giovanni Tomasello, MD

    University of Palermo

    STUDY DIRECTOR

  • Francesco Cappello, MD

    University of Palermo

    STUDY CHAIR

  • Provvidenza Damiani, MD

    University of Palermo

    PRINCIPAL INVESTIGATOR

  • Manfredi Rizzo, MD

    University of Palermo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 18, 2011

First Posted

November 23, 2011

Last Updated

December 12, 2017

Record last verified: 2017-12

Locations

IT(1)