Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer
- Conditions
- Colonic Neoplasms
- Interventions
- Dietary Supplement: citogenexOther: conventional therapy
- Registration Number
- NCT01477866
- Lead Sponsor
- University of Palermo
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 250
- stage IIIa-IIIc (AJCC/TNM)
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description citogenex conventional therapy citogenex + conventional therapy citogenex citogenex citogenex + conventional therapy conventional therapy conventional therapy conventional therapy
- Primary Outcome Measures
Name Time Method All cause mortality 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Palermo
🇮🇹Palermo, PA, Italy