Status:
COMPLETED
Prevention of Irinotecan Induced Diarrhea by Probiotics
Lead Sponsor:
Monsea Ltd.
Collaborating Sponsors:
Harmonium International Inc.
Pharma Agency
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Irinotecan is one of key drug used in the treatment of colorectal cancer. The incidence of irinotecan induced diarrhea varies between 60-90%, with severe diarrhea in 20-40%. The main cause of diarrhea...
Eligibility Criteria
Inclusion
- signed written informed consent
- histologically proven colorectal cancer patients started new line of chemotherapy based on irinotecan
- ECOG PS 0 - 1 at study entry
- life expectancy more than 3 months
- absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
Exclusion
- impossibility to take oral medication
- active infection treated by antibiotic therapy
- ileostomy
- hypersensitivity to study drug
- any concurrent malignancy other than non-melanoma skin cancer, no other cancer in past 5 years.
- serious concomitant systemic disorders or diseases incompatible with the study (at the discretion of investigator )
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01410955
Start Date
December 1 2011
End Date
January 1 2014
Last Update
January 23 2014
Active Locations (6)
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1
St.James Hospital and Clinic
Bardejov, Slovakia, 085 01
2
Oncologic Institute of St.Elisabeth OUSA
Bratislava, Slovakia, 81250
3
National Cancer Institute, Slovakia
Bratislava, Slovakia, 833 10
4
Zdravspol s r.o. - oncologic ambulance
Komárno, Slovakia, 94501