[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492681":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":62,"studyPopulation":55,"armGroups":63,"interventions":76,"overallOfficials":55,"centralContacts":84,"locations":94,"responsibleParty":111,"collaborators":55,"id":113,"slug":55,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":114,"sex":120,"minAge":121,"maxAge":55,"enrollmentInfo":122,"targetDuration":55,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":131,"overallStatus":97,"whyStopped":55,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Centre Georges Francois Leclerc","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":55},[9],{"measure":10,"description":11,"timeFrame":12},"Neuropathies will be graded by the oncologist using the NCI-CTCAE version 5.0.","Neuropathies will be graded by the oncologist using the NCI-CTCAE version 5.0. during the consultation with the oncologist at 3 months.\n\nThe AE graded from 1 to 5. Grade 1 is a better and grade 5 is a worst outcome.","At 3 months",[14,18,22,26,29,33,37,41,44,48,51,53],{"measure":15,"description":16,"timeFrame":17},"Evaluation of Neuropathic pain symptom inventory (NPSI) scores","Evaluation of Neuropathic pain symptom inventory scores by the questionnaire. The minimum value is 0 (no pain) and the maximum value is 10 (maximum pain)","At 12 weeks, 16 weeks, 6 months and 12 months",{"measure":19,"description":20,"timeFrame":21},"All peripheral neuropathies graded by the oncologist according to CTCAE V5.0","Assess the rate of grade ≥ 2 peripheral neuropathy by NCI-CTCAE V5.0 The AE graded from 2 to 5. Grade 2 is a better and grade 5 is a worst outcome.","Every 4 weeks for one year",{"measure":23,"description":24,"timeFrame":25},"Time to onset of grade ≥ 2 neuropathy.","Assess time to onset of grade ≥ 2 neuropathy by Kaplan-Meyer method The AE graded from 2 to 5. Grade 2 is a better and grade 5 is a worst outcome.","During 1 year",{"measure":27,"description":28,"timeFrame":21},"Number of toxicities attributable to OnLife® dietary supplement","Assess toxicities attributable to OnLife® dietary supplement by NCI-CTCAE V5.0",{"measure":30,"description":31,"timeFrame":32},"Number of participants with musculoskeletal and joint pain","Musculoskeletal and joint pain will be defined and graded according to the CTCAE v5.0 classification","At 12 weeks, 16 weeks 6 months and 12 months.",{"measure":34,"description":35,"timeFrame":36},"Compliance with the Onlife®\u002FPlacebo dietary supplement","Compliance with the Onlife®\u002FPlacebo dietary supplement will be assessed by the accounting for treatments returned by patients to the pharmacy.","16 weeks",{"measure":38,"description":39,"timeFrame":40},"Quality of life of participants","Quality of life will be assessed by the EORTC QLQ C30 self-questionnaires and its associated module Chemotherapy-Induced Peripheral Neuropathy (CIPN 20).\n\nThe minimum value is 1 (no way) and the maximum value is 4 (a lot)","At baseline and then every 4 weeks for 4 months and then at 6 and 12 months.",{"measure":42,"description":43,"timeFrame":25},"The number and rate of women with at least one dose reduction due to peripheral neuropathy.","By NCI-CTCAE V5.0",{"measure":45,"description":46,"timeFrame":47},"Name of all concomitant treatments administered for neuropathy","By recording data in the eCRF for both arms","At 12 weeks, 16 weeks, 6 months and 12 months.",{"measure":49,"description":50,"timeFrame":17},"Evaluation of Overall Neuropathy Limitations Scale (ONLS) scores","Evaluation of ONLS scores by the questionnaires. The minimum value is 0 (better outcome) and the maximum value is 5 (worse outcome)",{"measure":34,"description":52,"timeFrame":36},"Compliance with the Onlife®\u002FPlacebo dietary supplement will be assessed by the Morisky questionnaire",{"measure":54,"description":43,"timeFrame":25},"The number and rate of women with at least one discontinuation of PACLITAXEL due to peripheral neuropathy.",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":55,"primaryPurpose":59,"observationalModel":55,"timePerspective":55,"maskingInfo":60},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":61,"maskingDescription":55,"whoMasked":55},"NONE","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. This would limit the number of PACLITAXEL dose reductions and premature interruptions of this cehemotherapy, thus potentially improving the results in terms of antitumor efficacy while improving the quality of life of patients treated with weekly PACLITAXEL.\n\nTwo treatment arms :\n\n\\- ARM A : 20 patients included in the placebo arm (Standard chemotherapy with PACLITAXEL + placebo dietary supplement) ARM B : 40 patients included in the experimental arm (standard PACLITAXEL chemotherapy + OnLife® food supplement)",[64,70],{"label":65,"type":66,"description":67,"interventionNames":68},"Placebo","PLACEBO_COMPARATOR","Standard chemotherapy PACLITAXEL + placebo dietary supplement",[69],"Other: Placebo",{"label":71,"type":72,"description":73,"interventionNames":74},"OnLife®","EXPERIMENTAL","Standard chemotherapy + OnLife® dietary supplement",[75],"Drug: OnLife®",[77,81],{"type":78,"name":71,"description":79,"armGroupLabels":80,"otherNames":55},"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",[71],{"type":6,"name":65,"description":82,"armGroupLabels":83,"otherNames":55},"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",[65],[85,91],{"name":86,"role":87,"phone":88,"phoneExt":89,"email":90},"Didier MAYEUR, Doctor","CONTACT","03 80 73 75 00","+33","dmayeur@cgfl.fr",{"name":92,"role":87,"phone":88,"phoneExt":89,"email":93},"Emilie REDERSTORFF","erederstorff@cgfl.fr",[95],{"facility":96,"status":97,"city":98,"state":55,"zip":99,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"Centre Georges François Leclerc","RECRUITING","Dijon","21000","France","FR",{"type":103,"coordinates":104},"Point",[105,106],5.01391,47.31344,{"lat":106,"lon":105},[109],{"name":110,"role":87,"phone":55,"phoneExt":55,"email":90},"Didier MAYEUR, Dr",{"type":112,"investigatorFullName":55,"investigatorTitle":55,"investigatorAffiliation":55,"oldNameTitle":55,"oldOrganization":55},"SPONSOR","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":123,"type":124},60,"ESTIMATED","INTERVENTIONAL",[127],"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.",[130],"Breast Cancer",[132,133,134,135,136],"breast","neuropathy","OnLife","dietary supplement","Paclitaxel","2024-04-19",{"date":139,"type":140},"2024-04-22","ACTUAL",{"date":142,"type":140},"2024-04-12",{"date":144,"type":124},"2026-06-30",{"name":5,"class":6},1]