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Brief Title: Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer
Official Title: Utility Of Citogenex Administration In Patients With Colon-Rectal Cancer
Study ID: 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.
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.
Minimum Age: 40 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
University of Palermo, Palermo, PA, Italy
Name: Giovanni Tomasello, MD
Affiliation: University of Palermo
Role: STUDY_DIRECTOR
Name: Francesco Cappello, MD
Affiliation: University of Palermo
Role: STUDY_CHAIR
Name: Provvidenza Damiani, MD
Affiliation: University of Palermo
Role: PRINCIPAL_INVESTIGATOR
Name: Manfredi Rizzo, MD
Affiliation: University of Palermo
Role: PRINCIPAL_INVESTIGATOR