Randomized, Double Blind, Placebo Controlled, Cross-over Phase II Study on the Effects of Lactobacillus Rhamnosus GG Supplementation in Patients on 1st Line XELOXA Treatment for Metastatic Colorectal Cancer
This is a prospective, multicenter, randomized, cross-over, double-blind, placebo-controlled
study. Patients diagnosed with advanced colorectal cancer with overt distant metastases and
who will receive chemotherapy consisting of capecitabine, oxaliplatin and bevacizumab, given
as 3-weekly cycles, will be randomly assigned to receive either lactobacilli (GefilusR) or
placebo during the first 3 cycles of chemotherapy (for 9 weeks). Following this, the groups
will be crossed over and those study participants who were allocated to lactobacilli will
receive placebo for 9 weeks, and vice versa. Lactobacilli and placebo are administered twice
daily. The total daily dose of lactobacilli is 20 billion CFU. The primary outcome measure
is frequency of moderate/severe diarrhoea (grade 2-4). Adverse effects (including the
frequency of diarrhoea, flatulence, bloating, constipation, and nausea) will be
longitudinally monitored based on a patient diary and study visits. The study will also
address safety and tolerability of chemotherapy, response to chemotherapy, progression-free
survival, resectability of liver metastases, and serum growth factor levels. A total of 84
patients are planned to be entered.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Effect on the treatment-related grade 2 to 4 diarrhoea
18 weeks
No
Heikki Joensuu, M.D.
Study Director
Department of Oncology, Helsinki University Central Hospital
Finland: Finnish Medicines Agency
ML18581
NCT00197873
September 2005
October 2013
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