The pbjective of this study is to assess the impact of a multi-strain bacteria probiotic OXXYSLAB® on the reduction of oxaliplatin-induced peripheral neuropathy in patients with stage III colon cancer receiving FOLFOX or XELOX regimen in adjuvant treatment, assessed using the oxaliplatin-specific scale of Levi.
Patients are randomized (1:1 ratio), between: * Experimental group: Multi-strain PROBIOTIC treatment (OXXYSLAB®) 1.5 g sachet containing maltose and the OXXYSLAB® multi-strain probiotic formulation (eight different live bacterial strains, 200 billion bacteria). * Control group: PLACEBO treatment 1.5 g sachet strictly identical to OXXYSLAB®, containing maltose only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
130
PROBIOTIC treatment (OXXYSLAB®) starts 1 week before first administration of chemotherapy (XELOX or FOLFOX) and be continued until 1 week after end of the last cycle of chemotherapy. PROBIOTIC treatment (OXXYSLAB®) is administered orally , in 1 daily dose.
PLACEBO supplementation starts 1 week before first administration of chemotherapy (XELOX or FOLFOX) and be continued until 1 week after end of the last cycle of chemotherapy. PROBIOTIC treatment (OXXYSLAB®) is administered orally , in 1 daily dose.
Centre François Baclesse
Caen, Centre François Baclesse, France
Ch Aunay-Bayeux
Bayeux, France
CHU
Caen, France
Centre Oscar Lambret
Lille, France
Proportion of patients who experience a grade ≥2 peripheral neuropathy
Oxaliplatin-specific scale of Levi \[min grade 0 (better)- max Grade 4 (worse)\] after 6 cycles for FOLFOX or 4 cycles for XELOX
Time frame: Around week 12 (+/- 7 days) after initiation of treatment
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CHU
Lille, France
CHU
Rouen, France
CH
Saint-Lô, France