Impact of Probiotics on Neuropathy Induced by Adjuvant Chemotherapy in Patients With Colon Cancer.

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.

Inclusion criteria

• Patient ≥ 18 years
• Patient with histologically confirmed stage III adenocarcinoma colon cancer with curative resection
• Patient with an indication to start adjuvant oxaliplatin-based chemotherapy (FOLFOX 4 or XELOX regimen)
• ECOG performance status score of 0 or 1
• Patient must consent to allow the collection of fecal and blood samples during study for further ancillary studies
• Screening laboratory values must meet the following criteria:
• Neutrophils ≥ 1500/ mm³; Platelets ≥ 100 000/ mm³; Hemoglobin ≥ 9.0 g/dL
• Bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN
• Serum creatinine ≤ 1.5 x ULN or measured or calculated creatinine ≥ 50 ml/min clearance (CrCl) (using the Cockcroft-Gault formula)
• Patient with French language comprehension
• Female subject of childbearing potential must have a negative urine or serum pregnancy test within 7 days before study probiotics supplementation start
• Patient in reproductive age must be willing to use adequate contraception during study probiotics supplementation
• Patient affiliated to an appropriate social security system
• Patient has signed informed consent obtained before to any study specific procedures

Enclusion Criteria:

• Patient with any distant metastasis
• Patient with current peripheral neuropathy of any grade or ongoing treatment prescribed to prevent or treat peripheral neuropathy
• Patient with hypersensitivity to any ingredients in the composition of the multi-strain formulation and/or maltose
• Patient with history of acute pancreatitis
• Patient seriously immunosuppressed
• Patient with history of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)
• Patient using of probiotics or antibiotic treatments within one month before inclusion
• Patient with chronic inflammatory gastro-intestinal disease
• Patient with uracilemia ≥ 16 ng/ml
• Patient with QT/QTc > 450 msec for men and > 470 msec for women
• Patient with active infection requiring systemic therapy
• Patient with personality disorder or any other known progressive psychiatric pathology
• Patient with neurological previous history with ongoing symptoms (sequelae of head trauma, stroke, multiple sclerosis, epilepsy, neurodegenerative pathology, etc.)
• Patient with dependence on alcohol and / or drugs
• Pregnant or lactating woman
• Simultaneous participation in another clinical study that may compromise the conduct of this study.
• Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
• Patient deprived of liberty or placed under the authority of a tutor