Status:
COMPLETED
Impact of Probiotics BIFILACT® on Diarrhea in Patients Treated With Pelvic Radiation
Lead Sponsor:
CHU de Quebec-Universite Laval
Conditions:
Cancer
Diarrhea
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
In this double-blinded randomized clinical trial study, investigators assessed probiotic used to prevent or delay radiation induced grade moderate to severe diarrhea with patient treated for pelvic ca...
Detailed Description
This study was prospective, unicentric, controlled with comparison to a placebo, randomised and double-blinded. Patients were stratified into three groups: prostatic cancers, gynecologic cancers witho...
Eligibility Criteria
Inclusion
- They had a pelvic cancer: gynecologic, rectal, or prostatic,they were to receive radiotherapy treatments for a minimum of 40 Gy at the pelvic level , with or without chemotherapy and they had Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1
Exclusion
- they had previous radiotherapy treatments in the pelvic or abdominal region, medical history of gastro-intestinal inflammation, malabsorption syndrome or inflammatory bowel disease or coeliac disease, ileostomy, daily use of anti-diarrheal medication before radiotherapy, pregnancy or breastfeeding, neutropenia or probiotics intolerance
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT01839721
Start Date
December 1 2006
End Date
December 1 2010
Last Update
May 17 2013
Active Locations (1)
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1
CHU de Québec, radio-oncology departement
Québec, Quebec, Canada, G1R 2J6