Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 7:03 AM
Study NCT ID:
NCT06817161
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized double-blind prospective multicenter study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 116}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2025-01-29', 'studyFirstSubmitQcDate': '2025-02-04', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': 'At the beginning of Cycle 3 (each cycle is 21 days)".', 'description': 'Score of the QoL dimension relating to digestive symptoms according to the EORTC QLQ-OV28 self-questionnaire'}], 'secondaryOutcomes': [{'measure': 'The evolution of heart rate variability (HRV) during chemotherapy between the 2 groups of patients', 'timeFrame': 'Measured at inclusion and on day 1 of each course before chemotherapy infusion', 'description': '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'}, {'measure': 'The safety profile', 'timeFrame': 'During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion', 'description': 'Adverse events with regards to the use of the device, according to NCI-CTCAE V5.0'}, {'measure': 'The compliance with the use of the device', 'timeFrame': 'During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion', 'description': 'Number of daily taVNS stimulations and stimulation durations, taVNS (electrical) frequencies, according to ear device recordings'}, {'measure': '- The evolution of markers of inflammation (NLR, CRP, Albumin) during chemotherapy', 'timeFrame': 'At inclusion and during cycles 3 and 6 of chemotherapy (each cycle is 21 days)', 'description': '\\- Blood concentrations of inflammatory markers : Neutrophil to Lymphocyte Ratio (NLR), CRP, Albumin,'}, {'measure': 'Quality of life during chemotherapy', 'timeFrame': 'At inclusion, at courses 3 and 6 of chemotherapy (each cycle is 21 days)', 'description': 'Quality of life scores according to the standardized self-questionnaire EORTC QLQ-C30'}, {'measure': 'The dose-intensity of chemotherapy in first-line treatment', 'timeFrame': 'During chemotherapy (6 cycles, each cycle is 21 days), so up to 5 months after inclusion', 'description': 'Dose of chemotherapy delivered per time unit'}, {'measure': 'The progression-free survival', 'timeFrame': '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', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ovarian carinoma', 'parasympathetic', 'vagus nerve', 'transcutaneous auricular stimulation', 'quality of life', 'digestive symptoms'], 'conditions': ['Ovarian Carcinoma', 'First Line Chemotherapy', 'Digestive System Disorders']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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 (\\<2 years) of epileptic seizures\n* Proven severe cardiovascular disease (such as known FEV \\<40%, 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'}, 'identificationModule': {'nctId': 'NCT06817161', 'acronym': 'ESTANVO', 'briefTitle': 'Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer:', 'organization': {'class': 'OTHER', 'fullName': 'Centre Francois Baclesse'}, 'officialTitle': 'Benefit of Transcutaneous Auricular Vagus Nerve Stimulation in Improving Quality of Life in First Line Treatment of Ovarian Cancer: the ESTANVO Randomized Trial', 'orgStudyIdInfo': {'id': 'ESTANVO'}, 'secondaryIdInfos': [{'id': '2024-A01527-40', 'type': 'REGISTRY', 'domain': 'ID-RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'transcutaneous auricular vagus nerve stimulation (taVNS)', 'interventionNames': ['Device: transcutaneous auricular vagus nerve stimulation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'placebo using the same device that does not deliver electrical stimulation', 'interventionNames': ['Device: Placebo device']}], 'interventions': [{'name': 'transcutaneous auricular vagus nerve stimulation', 'type': 'DEVICE', 'description': '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)', 'armGroupLabels': ['Experimental group']}, {'name': 'Placebo device', 'type': 'DEVICE', 'description': '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)', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Caen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'François CHERIFI', 'role': 'CONTACT', 'email': 'f.cherifi@baclesse.unicancer.fr', 'phone': '33-231455050'}], 'facility': 'Centre François Baclesse', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Caen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Angélique DA SILVA', 'role': 'CONTACT', 'email': 'dasilva-a@chu-caen.fr', 'phone': '33-231063131'}], 'facility': 'CHU CAEN', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'city': 'Lille', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nora ALLOY', 'role': 'CONTACT', 'email': 'investigation@o-lambret.fr', 'phone': '33-3 20 29 59 59'}], 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Rouen', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sophie GOUERANT', 'role': 'CONTACT', 'email': 'sophie.gouerant@chb.unicancer.fr', 'phone': '33-232082985'}], 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'François CHERIFI, Medical Doctor', 'role': 'CONTACT', 'email': 'f.cherifi@baclesse.unicancer.fr', 'phone': '0231455050'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Francois Baclesse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}