[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100434452":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":37,"locations":43,"responsibleParty":142,"collaborators":27,"id":144,"slug":145,"hasResults":146,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":146,"sex":152,"minAge":153,"maxAge":27,"enrollmentInfo":154,"targetDuration":27,"studyType":157,"phases":158,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":58,"whyStopped":27,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":177},{"fullName":5,"class":6},"University Hospital, Tours","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"intervention","EXPERIMENTAL","standard anti emetic treatment use of non invasive vagal stimulation twice a day from the day before chemotherapy till 4 days after, with a transcutaneous auricular device. This stimulation is to be done for the three first cycles of chemotherapy.",[13,14],"Device: non invasive auricular vagal stimulation","Drug: usual medical treatment",{"label":16,"type":17,"description":18,"interventionNames":19},"control","SHAM_COMPARATOR","standard anti emetic treatment use of non invasive vagal stimulation twice a day from the day before chemotherapy till 4 days after, with a transcutaneous auricular sham device. This \"stimulation\" is to be done for the three first cycles of chemotherapy.",[14,20],"Device: sham stimulation",[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","non invasive auricular vagal stimulation","Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles",[9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"DRUG","usual medical treatment","Standard anti emetic treatments to prevent emesis due to chemotherapy",[16,9],{"type":23,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"sham stimulation","Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles, with a sham device",[16],[38],{"name":39,"role":40,"phone":41,"phoneExt":27,"email":42},"Mathilde CANCEL, MD","CONTACT","02 47 47 99 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CHRISTIANN","francois.christiann@ch-chateauroux.fr",{"name":94,"role":70,"phone":27,"phoneExt":27,"email":27},{"facility":98,"status":58,"city":99,"state":27,"zip":27,"country":48,"countryCode":49,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Clinique Victor Hugo","Le Mans",{"type":51,"coordinates":101},[102,103],0.20251,48.0021,{"lat":103,"lon":102},[106,109],{"name":107,"role":40,"phone":27,"phoneExt":27,"email":108},"Hugues BOURGEOIS","h.bourgeois@ilcgroupe.fr",{"name":107,"role":70,"phone":27,"phoneExt":27,"email":27},{"facility":111,"status":46,"city":112,"state":27,"zip":27,"country":48,"countryCode":49,"cosmosGeoPoint":113,"geoPoint":117,"contacts":27},"Ch Orleans","Orléans",{"type":51,"coordinates":114},[115,116],1.90407,47.90248,{"lat":116,"lon":115},{"facility":119,"status":58,"city":120,"state":27,"zip":27,"country":48,"countryCode":49,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Ch Chinon","Saint-Benoît-la-Forêt",{"type":51,"coordinates":122},[123,124],0.3227,47.22299,{"lat":124,"lon":123},[127,130],{"name":128,"role":40,"phone":27,"phoneExt":27,"email":129},"Marion STACOFFE","m.stacoffe@chu-tours.fr",{"name":128,"role":70,"phone":27,"phoneExt":27,"email":27},{"facility":132,"status":58,"city":133,"state":27,"zip":27,"country":48,"countryCode":49,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"CHRU Bretonneau","Tours",{"type":51,"coordinates":135},[136,137],0.70398,47.39484,{"lat":137,"lon":136},[140,141],{"name":39,"role":40,"phone":27,"phoneExt":27,"email":42},{"name":39,"role":70,"phone":27,"phoneExt":27,"email":27},{"type":143,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100434452","efficacy-and-safety-of-non-invasive-vagal-stimulation-to-prevent-chemotherapy-induced-nausea-100434452",false,"NCT04937309","Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea","Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea in Patients With Breast Cancer Receiving Anthracycline and Cyclophosphamide Chemotherapy","SILENCE","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) status 0 to 2\n* patient with breast cancer planned to receive Anthracycline and Cyclophosphamide chemotherapy\n* informed consent\n* compliance expected\n* social security affiliation\n\nExclusion Criteria:\n\n* nausea or vomiting 24h or less, before inclusion\n* Antiemetic drug intake in the last 72h before inclusion\n* Central nervous system metastasis\n* Daily alcohol intake\n* Prior chemotherapy\n* Cardiac arrythmia, severe heart failure\n* Device for sleep apnea\n* History of arterial or venous thrombosis, or thrombophlebitis\n* Vagotomy\n* Vagal stimulation ongoing\n* Skin disease on the stimulation zone\n* Cochlear implant next to the stimulation zone\n* Unable to use the vagal stimulation device due to left ear unusual shape\n* Pregnant or breastfeeding women, or women of childbearing age without effective contraception\n* Documented allergy or contraindication to one of the antiemesis drugs required in the study\n* Protected adults (individuals under guardianship by court order)\n* Unable to read or write","ALL","18 Years",{"count":155,"type":156},338,"ESTIMATED","INTERVENTIONAL",[159],"NA","Despite pharmaceutical innovations, chemotherapy induced nausea is frequent and largely participating to alter our patients quality of life.\n\nNon invasive vagal stimulation is approved in other health issues, for example in headache or gastroparesis, with a reported benefit on nausea.\n\nThis study aims to analyse if a non invasive vagal stimulation could better prevent chemotherapy induced nausea, in addition to standard treatment, in breast cancer patients treated with cyclophosphamide and anthracycline.",[162],"Breast Cancer",[164,165,166,167],"nausea","non invasive vagal stimulation","chemotherapy","breast cancer","2026-06-16",{"date":170,"type":171},"2026-06-17","ACTUAL",{"date":173,"type":171},"2022-06-23",{"date":175,"type":156},"2028-09-30",{"name":5,"class":6},8]