Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer (CITOGENEX PA)
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Purpose
The main aim of the present study is to test the efficacy and safety of CITOGENEX administration in patients with colon-rectal cancer.
| Condition | Intervention |
|---|---|
|
Colonic Neoplasms |
Dietary Supplement: citogenex Other: conventional therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer |
- All cause mortality [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 250 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- stage IIIa-IIIc (AJCC/TNM)
Contacts and Locations| Italy | |
| University of Palermo | |
| Palermo, PA, Italy, 90129 | |
| 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 |
More Information
No publications provided
| Responsible Party: | Manfredi Rizzo, Assistant Professor, University of Palermo |
| ClinicalTrials.gov Identifier: | NCT01477866 History of Changes |
| Other Study ID Numbers: | CITOGENEX CRC |
| Study First Received: | November 18, 2011 |
| Last Updated: | October 25, 2012 |
| Health Authority: | Italy: National Monitoring Centre for Clinical Trials - Ministry of Health |
Additional relevant MeSH terms:
|
Neoplasms Rectal Neoplasms Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Colonic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013