[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649432":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":117,"collaborators":26,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":121,"sex":127,"minAge":128,"maxAge":26,"enrollmentInfo":129,"targetDuration":26,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":143,"whyStopped":26,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Centre Francois Baclesse","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","Multi-strain PROBIOTIC treatment",[13],"Dietary Supplement: PROBIOTIC SUPPLEMENTATION BY OXXYSLAB®",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","PLACEBO_COMPARATOR","PLACEBO treatment",[19],"Dietary Supplement: PLACEBO supplementation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","PROBIOTIC SUPPLEMENTATION BY OXXYSLAB®","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.\n\nPROBIOTIC treatment (OXXYSLAB®) is administered orally , in 1 daily dose.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"PLACEBO supplementation","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.\n\nPROBIOTIC treatment (OXXYSLAB®) is administered orally , in 1 daily dose.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Mélanie DOS SANTOS, MD","CONTACT","+33231455050","m.dossantos@baclesse.unicancer.fr",[38,53,65,74,86,94,105],{"facility":39,"status":26,"city":40,"state":39,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Centre François Baclesse","Caen","14076","France","FR",{"type":45,"coordinates":46},"Point",[47,48],-0.35912,49.18585,{"lat":48,"lon":47},[51],{"name":33,"role":34,"phone":52,"phoneExt":26,"email":36},"0231455050",{"facility":54,"status":26,"city":55,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Ch Aunay-Bayeux","Bayeux",{"type":45,"coordinates":57},[58,59],-0.7039,49.27732,{"lat":59,"lon":58},[62],{"name":63,"role":34,"phone":26,"phoneExt":26,"email":64},"Anne PEYTIER","a.peytier@ch-ab.fr",{"facility":66,"status":26,"city":40,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":67,"geoPoint":69,"contacts":70},"CHU",{"type":45,"coordinates":68},[47,48],{"lat":48,"lon":47},[71],{"name":72,"role":34,"phone":26,"phoneExt":26,"email":73},"Karine BOUHIER-LEPORRIER","bouhierleporrier-k@chu-caen.fr",{"facility":75,"status":26,"city":76,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Centre Oscar Lambret","Lille",{"type":45,"coordinates":78},[79,80],3.05512,50.63391,{"lat":80,"lon":79},[83],{"name":84,"role":34,"phone":26,"phoneExt":26,"email":85},"Flore PIGNON","f-pignon@o-lambret.fr",{"facility":66,"status":26,"city":76,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":87,"geoPoint":89,"contacts":90},{"type":45,"coordinates":88},[79,80],{"lat":80,"lon":79},[91],{"name":92,"role":34,"phone":26,"phoneExt":26,"email":93},"Anne PLOQUIN","anne.ploquin@chu-lille.fr",{"facility":66,"status":26,"city":95,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Rouen",{"type":45,"coordinates":97},[98,99],1.09932,49.44313,{"lat":99,"lon":98},[102],{"name":103,"role":34,"phone":26,"phoneExt":26,"email":104},"Adrien GRANCHER","Adrien.Grancher@chu-rouen.fr",{"facility":106,"status":26,"city":107,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"CH","Saint-Lô",{"type":45,"coordinates":109},[110,111],-1.09031,49.11624,{"lat":111,"lon":110},[114],{"name":115,"role":34,"phone":26,"phoneExt":26,"email":116},"Jérôme MEUNIER","jerome.meunier@ch-stlo.fr",{"type":118,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100649432","impact-of-probiotics-on-neuropathy-induced-by-adjuvant-chemotherapy-in-patients-with-colon-cancer-100649432",false,"NCT07733817","Impact of Probiotics on Neuropathy Induced by Adjuvant Chemotherapy in Patients With Colon Cancer.","Impact of Probiotic Supplementation on Neuropathy Induced by Adjuvant Chemotherapy in Patients With Colon Cancer: a Phase III Randomized Study","PROBIOCOL","Inclusion Criteria:\n\n* Patient ≥ 18 years\n* Patient with histologically confirmed stage III adenocarcinoma colon cancer with curative resection\n* Patient with an indication to start adjuvant oxaliplatin-based chemotherapy (FOLFOX 4 or XELOX regimen)\n* ECOG performance status score of 0 or 1\n* Patient must consent to allow the collection of fecal and blood samples during study for further ancillary studies\n* Screening laboratory values must meet the following criteria:\n* Neutrophils ≥ 1500\u002F mm³; Platelets ≥ 100 000\u002F mm³; Hemoglobin ≥ 9.0 g\u002FdL\n* Bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 3 x ULN\n* Serum creatinine ≤ 1.5 x ULN or measured or calculated creatinine ≥ 50 ml\u002Fmin clearance (CrCl) (using the Cockcroft-Gault formula)\n* Patient with French language comprehension\n* Female subject of childbearing potential must have a negative urine or serum pregnancy test within 7 days before study probiotics supplementation start\n* Patient in reproductive age must be willing to use adequate contraception during study probiotics supplementation\n* Patient affiliated to an appropriate social security system\n* Patient has signed informed consent obtained before to any study specific procedures\n\nEnclusion Criteria:\n\n* Patient with any distant metastasis\n* Patient with current peripheral neuropathy of any grade or ongoing treatment prescribed to prevent or treat peripheral neuropathy\n* Patient with hypersensitivity to any ingredients in the composition of the multi-strain formulation and\u002For maltose\n* Patient with history of acute pancreatitis\n* Patient seriously immunosuppressed\n* Patient with history of other malignancy within the previous 3 years (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)\n* Patient using of probiotics or antibiotic treatments within one month before inclusion\n* Patient with chronic inflammatory gastro-intestinal disease\n* Patient with uracilemia ≥ 16 ng\u002Fml\n* Patient with QT\u002FQTc \\> 450 msec for men and \\> 470 msec for women\n* Patient with active infection requiring systemic therapy\n* Patient with personality disorder or any other known progressive psychiatric pathology\n* Patient with neurological previous history with ongoing symptoms (sequelae of head trauma, stroke, multiple sclerosis, epilepsy, neurodegenerative pathology, etc.)\n* Patient with dependence on alcohol and \u002F or drugs\n* Pregnant or lactating woman\n* Simultaneous participation in another clinical study that may compromise the conduct of this study.\n* Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol\n* Patient deprived of liberty or placed under the authority of a tutor","ALL","18 Years",{"count":130,"type":131},130,"ESTIMATED","INTERVENTIONAL",[134],"NA","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.",[137,138],"Colon Adenocarcinoma","Neuropathic Pain",[140,141,142],"FOLFOX","PROBIOTICS","XELOX","NOT_YET_RECRUITING","2026-07-29",{"date":146,"type":147},"2026-07-30","ACTUAL",{"date":149,"type":131},"2026-10-01",{"date":151,"type":131},"2036-04-01",{"name":5,"class":6},7]