protocolSection identificationModule nctId: NCT06341985, orgStudyIdInfo id: IEO 1593, briefTitle: DOsimetry and Radiation Induced NAusea in Head and Neck Cancers, acronym: DORIAN, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-15, primaryCompletionDateStruct date: 2024-11-15, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: European Institute of Oncology, class: OTHER, descriptionModule briefSummary: This is a prospective cohort study for the analysis of correlation between dosimetric parameters and RANV (Radiation Associated Nausea and Vomiting) in patients with head and neck cancer undergoing exclusive radiotherapy (RT).The primary purpose of this study is to search for a potential correlation between dosimetry and physician- and patient-rated symptoms in patients treated with exclusive radiotherapy for head and neck cancer., conditionsModule conditions: Head and Neck Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: Exclusive radiotherapy, outcomesModule primaryOutcomes measure: Evaluation of nausea (acute toxicity) using CTCAE V5.0, secondaryOutcomes measure: Evaluation of nausea (acute toxicity) using M.D. Anderson Symptom Inventory (MDASI-SCORE) questionnaire, secondaryOutcomes measure: Identification of the organs at risk most strongly correlated with the onset of nausea, secondaryOutcomes measure: Identification of dosimetric cutoffs for the onset of nausea, secondaryOutcomes measure: Comparison of dosimetric analysis between 3D conformal, IMRT and proton therapy techniques, secondaryOutcomes measure: Development of machine-learning predictive models for the onset of nausea, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona, status: RECRUITING, city: Ancona, country: Italy, contacts name: Giovanna Mantello, role: CONTACT, email: clelia.dicarlo@ospedaliriuniti.marche.it, geoPoint lat: 43.5942, lon: 13.50337, locations facility: Ospedale "Mons. Dimiccoli", status: RECRUITING, city: Barletta, country: Italy, contacts name: Alessia Di Rito, role: CONTACT, email: aledirito@yahoo.it, geoPoint lat: 41.31429, lon: 16.28165, locations facility: Azienda Ospedaliera S.Pio, status: RECRUITING, city: Benevento, country: Italy, contacts name: Angela Argenone, role: CONTACT, email: angela.argenone@ao-rummo.it, geoPoint lat: 41.1307, lon: 14.77816, locations facility: Ospedale MultiMedica, status: RECRUITING, city: Castellanza, country: Italy, contacts name: Gianpiero Catalano, role: CONTACT, email: gianpiero.catalano@multimedica.it, geoPoint lat: 45.61079, lon: 8.89616, locations facility: IRCCS Ospedale Policlinico San Martino, status: RECRUITING, city: Genova, country: Italy, contacts name: Liliana Belgioia, role: CONTACT, email: liliana.belgioia@unige.it, geoPoint lat: 44.40478, lon: 8.94438, locations facility: European Institute of Oncology, status: RECRUITING, city: Milan, country: Italy, contacts name: Stefania Volpe, role: CONTACT, geoPoint lat: 45.46427, lon: 9.18951, locations facility: IRCCS Ospedale San Raffaele, status: RECRUITING, city: Milan, country: Italy, contacts name: Italo Dell'Oca, role: CONTACT, email: delloca.italo@hsr.it, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Azienda Ospedaliero-Universitaria di Modena, status: RECRUITING, city: Modena, country: Italy, contacts name: Elisa D'Angelo, role: CONTACT, email: dangelo.elisa@policlinico.mo.it, geoPoint lat: 44.64783, lon: 10.92539, locations facility: Azienda Ospedaliero Universitaria Ospedale Maggiore della Carità di Novara, status: RECRUITING, city: Novara, country: Italy, contacts name: Carla Pisani, role: CONTACT, email: carla.pisani@maggioreosp.novara.it, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Fondazione IRCCS Policlinico San Matteo, status: RECRUITING, city: Pavia, country: Italy, contacts name: Sara Colombo, role: CONTACT, email: s.colombo@smatteo.pv.it, geoPoint lat: 45.19205, lon: 9.15917, locations facility: Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata, status: RECRUITING, city: Roma, country: Italy, contacts name: Giuseppina Apicella, role: CONTACT, email: gapicella@hsangiovanni.roma.it, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Azienda Ospedaliero Universitaria Policlinico Umberto I, status: RECRUITING, city: Roma, country: Italy, contacts name: Francesca De Felice, role: CONTACT, email: francesca.defelice@uniroma1.it, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina, status: RECRUITING, city: Roma, country: Italy, contacts name: Orietta Caspiani, role: CONTACT, email: o.caspiani@gmail.com, geoPoint lat: 41.89193, lon: 12.51133, locations facility: I.R.C.C.S. MultiMedica - Sesto San Giovanni, status: RECRUITING, city: Sesto San Giovanni, country: Italy, contacts name: Gianpiero Catalano, role: CONTACT, email: gianpiero.catalano@multimedica.it, geoPoint lat: 45.53329, lon: 9.22585, hasResults: False