A Randomized Controlled Trial of the Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Efficacy
Compare the frequency of diarrheal events grade 2 or greater by CTCAE version 4.0 in patients receiving abdominal or pelvic chemoradiation with a fluoropyrimidine who are treated with the probiotic LGG to the frequency of these events in patients receiving abdominal or pelvic chemoradiation with a fluoropyrimidine who receive placebo
14 months
No
Matthew Ciorba, M.D.
Principal Investigator
Washington University School of Medicine
United States: Institutional Review Board
12-X387
NCT01790035
April 2013
August 2015
Name | Location |
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Washington University School of Medicine | Saint Louis, Missouri 63110 |