[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578889":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":51,"studyPopulation":40,"armGroups":52,"interventions":65,"overallOfficials":40,"centralContacts":74,"locations":80,"responsibleParty":134,"collaborators":40,"id":136,"slug":40,"hasResults":137,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":137,"sex":143,"minAge":144,"maxAge":40,"enrollmentInfo":145,"targetDuration":40,"studyType":148,"phases":149,"briefSummary":151,"conditions":152,"keywords":156,"overallStatus":83,"whyStopped":40,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Centre Francois Baclesse","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"assess the impact of stimulation of parasympathetic activity by transcutaneous auricular vagus nerve stimulation (taVNS) on quality of life (QoL) relating to digestive symptoms in patients undergoing first-line treatment for ovarian cancer, as compared t","Score of the QoL dimension relating to digestive symptoms according to the EORTC QLQ-OV28 self-questionnaire","At the beginning of Cycle 3 (each cycle is 21 days)\".",[14,18,22,25,29,33,36],{"measure":15,"description":16,"timeFrame":17},"The evolution of heart rate variability (HRV) during chemotherapy between the 2 groups of patients","Heart Rate Variability (HRV) parameters through an electrocardiogram; as an exploratory complementary objective, for patients in Caen centres, HRV will also be measured using a Polar H10 type measuring device to determine two parameters SDDN and RMSSD","Measured at inclusion and on day 1 of each course before chemotherapy infusion",{"measure":19,"description":20,"timeFrame":21},"The safety profile","Adverse events with regards to the use of the device, according to NCI-CTCAE V5.0","During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion",{"measure":23,"description":24,"timeFrame":21},"The compliance with the use of the device","Number of daily taVNS stimulations and stimulation durations, taVNS (electrical) frequencies, according to ear device recordings",{"measure":26,"description":27,"timeFrame":28},"- The evolution of markers of inflammation (NLR, CRP, Albumin) during chemotherapy","\\- Blood concentrations of inflammatory markers : Neutrophil to Lymphocyte Ratio (NLR), CRP, Albumin,","At inclusion and during cycles 3 and 6 of chemotherapy (each cycle is 21 days)",{"measure":30,"description":31,"timeFrame":32},"Quality of life during chemotherapy","Quality of life scores according to the standardized self-questionnaire EORTC QLQ-C30","At inclusion, at courses 3 and 6 of chemotherapy (each cycle is 21 days)",{"measure":34,"description":35,"timeFrame":21},"The dose-intensity of chemotherapy in first-line treatment","Dose of chemotherapy delivered per time unit",{"measure":37,"description":38,"timeFrame":39},"The progression-free survival","Progression-free survival (PFS) defined as time between randomization and first disease progression according to RECIST v1.1 criteria or death whatever cause (in the absence of progression)","From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":44,"primaryPurpose":6,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"RANDOMIZED","PARALLEL","Randomized double-blind prospective multicenter study",{"masking":46,"maskingDescription":40,"whoMasked":47},"TRIPLE",[48,49,50],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","Impact of stimulation of parasympathetic activity by transcutaneous auricular vagus nerve stimulation (taVNS) on quality of life (QoL) relating to digestive symptoms in patients undergoing first-line treatment for ovarian cancer, as compared to shame taVNS\n\nRandomization between:\n\n* Experimental group: transcutaneous auricular vagus nerve stimulation (taVNS)\n* Control group: placebo using the same device that does not deliver electrical stimulation",[53,59],{"label":54,"type":55,"description":56,"interventionNames":57},"Experimental group","EXPERIMENTAL","transcutaneous auricular vagus nerve stimulation (taVNS)",[58],"Device: transcutaneous auricular vagus nerve stimulation",{"label":60,"type":61,"description":62,"interventionNames":63},"Control group","PLACEBO_COMPARATOR","placebo using the same device that does not deliver electrical stimulation",[64],"Device: Placebo device",[66,71],{"type":67,"name":68,"description":69,"armGroupLabels":70,"otherNames":40},"DEVICE","transcutaneous auricular vagus nerve stimulation","The intervention begins on the first day of chemotherapy and continues daily until 21 days after the end of chemotherapy (6 cycles).\n\nThe dispositive is used every day at home, twice daily (during 30 minutes)",[54],{"type":67,"name":72,"description":69,"armGroupLabels":73,"otherNames":40},"Placebo device",[60],[75],{"name":76,"role":77,"phone":78,"phoneExt":40,"email":79},"François CHERIFI, Medical Doctor","CONTACT","0231455050","f.cherifi@baclesse.unicancer.fr",[81,97,108,121],{"facility":82,"status":83,"city":84,"state":40,"zip":40,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"Centre François Baclesse","RECRUITING","Caen","France","FR",{"type":88,"coordinates":89},"Point",[90,91],-0.35912,49.18585,{"lat":91,"lon":90},[94],{"name":95,"role":77,"phone":96,"phoneExt":40,"email":79},"François CHERIFI","33-231455050",{"facility":98,"status":99,"city":84,"state":40,"zip":40,"country":85,"countryCode":86,"cosmosGeoPoint":100,"geoPoint":102,"contacts":103},"CHU CAEN","NOT_YET_RECRUITING",{"type":88,"coordinates":101},[90,91],{"lat":91,"lon":90},[104],{"name":105,"role":77,"phone":106,"phoneExt":40,"email":107},"Angélique DA SILVA","33-231063131","dasilva-a@chu-caen.fr",{"facility":109,"status":99,"city":110,"state":40,"zip":40,"country":85,"countryCode":86,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Centre Oscar Lambret","Lille",{"type":88,"coordinates":112},[113,114],3.05512,50.63391,{"lat":114,"lon":113},[117],{"name":118,"role":77,"phone":119,"phoneExt":40,"email":120},"Nora ALLOY","33-3 20 29 59 59","investigation@o-lambret.fr",{"facility":122,"status":99,"city":123,"state":40,"zip":40,"country":85,"countryCode":86,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Centre Henri Becquerel","Rouen",{"type":88,"coordinates":125},[126,127],1.09932,49.44313,{"lat":127,"lon":126},[130],{"name":131,"role":77,"phone":132,"phoneExt":40,"email":133},"Sophie GOUERANT","33-232082985","sophie.gouerant@chb.unicancer.fr",{"type":135,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100578889",false,"NCT06817161","Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer:","Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer: the ESTANVO Randomized Trial","ESTANVO","Inclusion Criteria:\n\n* Patient ≥ 18 years old\n* ECOG 0-2\n* Histologically proven epithelial ovarian carcinoma\n* FIGO stage ≥ IIB\n* Patient candidate for first line chemotherapy treatment (alone, neoadjuvant or adjuvant)\n* Patient affiliated to an appropriate social security system\n* Patient who has signed informed consent obtained before any trial related activities\n\nExclusion Criteria:\n\n* Patient with an active implantable medical device or any other implanted electronic or electrical device (pacemaker, defibrillator, etc.)\n* Dermatological problems in the area where stimulation electrodes are applied\n* Recent history (\\\u003C2 years) of epileptic seizures\n* Proven severe cardiovascular disease (such as known FEV \\\u003C40%, severe valvulpathy…) or HRV analysis not possible (such as uncontrolled atrial fibrillation)\n* Serious ear pathology\n* Documented vegetative neuropathy\n* Unusual morphology of the left ear which does not allow the use of the device\n* Patient with a cochlear implant near to the stimulation site\n* Impaired cognitive abilities\n* Concurrent other malignancy (except for appropriately treated in-situ cervix carcinoma and non-melanoma skin carcinoma)\n* Pregnant or breastfeeding 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","FEMALE","18 Years",{"count":146,"type":147},116,"ESTIMATED","INTERVENTIONAL",[150],"PHASE3","Impact of stimulation of parasympathetic activity by transcutaneous auricular vagus nerve stimulation (taVNS) on quality of life (QoL) relating to digestive symptoms in patients undergoing first-line treatment for ovarian cancer, as compared to shame taVNS",[153,154,155],"Ovarian Carcinoma","First Line Chemotherapy","Digestive System Disorders",[157,158,159,160,161,162],"ovarian carinoma","parasympathetic","vagus nerve","transcutaneous auricular stimulation","quality of life","digestive symptoms","2025-10-03",{"date":165,"type":166},"2025-10-07","ACTUAL",{"date":168,"type":166},"2025-04-30",{"date":170,"type":147},"2028-09-30",{"name":5,"class":6},4]