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

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.

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