[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492681":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":56,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":25,"enrollmentInfo":68,"targetDuration":25,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Centre Georges Francois Leclerc","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Standard chemotherapy PACLITAXEL + placebo dietary supplement",[13],"Other: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"OnLife®","EXPERIMENTAL","Standard chemotherapy + OnLife® dietary supplement",[19],"Drug: OnLife®",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","It is administered for the duration of PACLITAXEL chemotherapy with the first administration performed 5 days before the first PACLITAXEL administration. The OnLife supplement will be continued for another 4 weeks after the last PACLITAXEL administration.\n\nOne tablet in the morning and one in the evening daily",[15],null,{"type":6,"name":9,"description":27,"armGroupLabels":28,"otherNames":25},"It is administered for the duration of PACLITAXEL chemotherapy with the first administration performed 5 days before the first PACLITAXEL administration. Placebo will be continued for another 4 weeks after the last PACLITAXEL administration.\n\nOne tablet in the morning and one in the evening daily",[9],[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Didier MAYEUR, Doctor","CONTACT","03 80 73 75 00","+33","dmayeur@cgfl.fr",{"name":37,"role":32,"phone":33,"phoneExt":34,"email":38},"Emilie REDERSTORFF","erederstorff@cgfl.fr",[40],{"facility":41,"status":42,"city":43,"state":25,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Centre Georges François Leclerc","RECRUITING","Dijon","21000","France","FR",{"type":48,"coordinates":49},"Point",[50,51],5.01391,47.31344,{"lat":51,"lon":50},[54],{"name":55,"role":32,"phone":25,"phoneExt":25,"email":35},"Didier MAYEUR, Dr",{"type":57,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100492681","phase-2-randomized-study-versus-placebo-for-the-prevention-of-neurotoxicity-induced-by-weekly-paclitaxel-100492681",false,"NCT05695313","Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL","Phase II Multicentric, Randomized Study Versus Placebo for the Prevention of Neurotoxicity Induced by Weekly PACLITAXEL","NEUROTAX","Inclusion Criteria:\n\n* Breast cancer patient with neo-adjuvant or adjuvant management, with an indication for weekly PACLITAXEL 80 mg\u002Fm² for 12 courses.\n* Age ≥ 18 years\n* Performans Status ≤ 3 according to Karnofsky and life expectancy greater than 6 months\n* For patients of childbearing age, effective contraception while taking Onlife®\u002Fplacebo.\n* Patient able to swallow OnLife\u002Fplacebo® tablets easily\n* Patient able and willing to follow all study procedures (including the completion of numerous questionnaires) in accordance with the protocol\n* Patient has understood, signed and dated the consent form\n* Patient affiliated to the social security system\n\nExclusion Criteria:\n\n* Patient previously started on PACLITAXEL\n* Known allergy to any of the substances in the study product Onlife®\u002Fplacebo (fish oil product)\n* Diabetes\n* Exogenous (Alcoholism)\n* History of peripheral neuropathy at inclusion and\u002For presence of sensory and\u002For motor disorders due to other neurological diseases\n* Pregnant or breastfeeding woman\n* Other uncontrolled progressive pathologies\n* Impossible or random follow-up\n* Persons deprived of liberty or under guardianship (including curatorship)\n* Inability to submit to the medical follow-up of the trial for geographical, social or psychological reasons.","FEMALE","18 Months",{"count":69,"type":70},60,"ESTIMATED","INTERVENTIONAL",[73],"PHASE2","This study recommends the use of OnLife dietary supplement, which will be followed by a few day before the initiation of PACLITAXEL, for the prevention of PACLITAXEL induced neuropathy. OnLife will be continued one month after stopping chemotherapy.\n\nThis would limit the number of PACLITAXEL dose reductions and premature interruptions of this chemotherapy, thus potentially improving the results in terms of antitumor efficacy, while improving the quality of life of patients treated with weekly PACLITAXEL.",[76],"Breast Cancer",[78,79,80,81,82],"breast","neuropathy","OnLife","dietary supplement","Paclitaxel","2024-04-19",{"date":85,"type":86},"2024-04-22","ACTUAL",{"date":88,"type":86},"2024-04-12",{"date":90,"type":70},"2026-06-30",{"name":5,"class":6},1]