[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100447451":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":72,"collaborators":31,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":31,"enrollmentInfo":85,"targetDuration":31,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":52,"whyStopped":31,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Universidad de Granada","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Group PBM_1","EXPERIMENTAL","Energy density 7.5 J \u002F cm2 for group PBM\\_1",[13],"Device: Energy density photobiomodulation (7.5)",{"label":15,"type":10,"description":16,"interventionNames":17},"Group PBM_2","Energy density 3 J \u002F cm2 for group PBM\\_2",[18],"Device: Energy density photobiomodulation (3)",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo Control","PLACEBO_COMPARATOR","The placebo control group will carry out the same protocol used in irradiated patients (including the use of protective glasses) using the same laser device to imitate a real irradiation; however, the device will be turned off and a recording of the emission sounds will be used to give the patient the hearing sensation of the laser therapy.",[24],"Device: Sham placebo",[26,32,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Energy density photobiomodulation (7.5)","A total of 22 points will be treated (extraoral and intraoral). 2 sessions per week, for 3 months (24 sessions in total). In addition, a mobile health application (LAXER) will be provided.",[9],null,{"type":27,"name":33,"description":29,"armGroupLabels":34,"otherNames":31},"Energy density photobiomodulation (3)",[15],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":31},"Sham placebo","In addition, a mobile health application (LAXER) will be provided.",[20],[40],{"name":41,"affiliation":5,"role":42},"Noelia Galiano-Castillo, PhD","PRINCIPAL_INVESTIGATOR",[44],{"name":41,"role":45,"phone":46,"phoneExt":47,"email":48},"CONTACT","699197690","+34","noeliagaliano@ugr.es",[50],{"facility":51,"status":52,"city":53,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Faculty of Health Sciences","RECRUITING","Granada","18070","Spain","ES",{"type":58,"coordinates":59},"Point",[60,61],-3.60667,37.18817,{"lat":61,"lon":60},[64,65,68,70],{"name":41,"role":45,"phone":31,"phoneExt":31,"email":31},{"name":66,"role":67,"phone":31,"phoneExt":31,"email":31},"Maria de la Cabeza Lopez-Garzon, MsC","SUB_INVESTIGATOR",{"name":69,"role":67,"phone":31,"phoneExt":31,"email":31},"Elisa Paula Postigo-Martin, MsC",{"name":71,"role":67,"phone":31,"phoneExt":31,"email":31},"Mario Lozano-Lozano, PhD",{"type":42,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Noelia Galiano-Castillo","Principal Investigator","100447451","photobiomodulation-therapy-plus-m-health-in-head-and-neck-cancer-patients-laxer-study-100447451",false,"NCT05106608","Photobiomodulation Therapy Plus M-health in Head and Neck Cancer Patients: LAXER Study","Photobiomodulation Therapy With M-health Tool for the Management of Oral Health and Quality of Life in Head and Neck Cancer Patients: LAXER Study","LAXER","Patients will be included in the study if they meet the following inclusion criteria:\n\n* men or women aged 18 years or older and were diagnosed with HNC.\n* chronic xerostomia.\n* received RT in the parotid, submandibular and\u002For sublingual salivary glands.\n* grade 3 oral dryness according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE).\n* medical treatment completed and in complete remission.\n* received medical clearance for participation in this study.\n* at least one month passed since the end of RT to avoid the possible presence of oral mucositis and\u002For radiodermatitis, which limits adherence to treatment and maximum 36 months.\n* no history of drugs\u002Fdevices\u002Fproducts (pilocarpine, cevimeline, amifostine, oral devices, humidifiers, or herbs) to prevent or treat xerostomia prior to study inclusion or no change in their use (no change in type or dose) for two months prior to study inclusion.\n* and able to access mobile applications or living with someone who has this ability.\n\nThe exclusion criteria will be as follows:\n\n* patients with metastases.\n* a score \\\u003C60 on the Karnofsky Performance Status Scale.\n* contraindications to receiving PBM therapy (e.g., cardiac arrhythmias, pacemakers, photosensitivity, drugs with photosensitizing action, and pregnancy).\n* other comorbidities such as diabetes and polypharmacy.\n* and retraction of the declaration of consent.","ALL","18 Years",{"count":86,"type":87},60,"ESTIMATED","INTERVENTIONAL",[90],"NA","The Photobiomodulation therapy could have positive effects on quality of life and oral health in head and neck cancer survivors post-radiotherapy. The improvement in quality of life will be maintained after a follow-up period.",[93,94,95],"Head and Neck Cancer","Head and Neck Neoplasms","Xerostomia",[97,98,95,99,100],"Quality of Life","Neoplasms","Low-Level Light Therapy","Telemedicine","2025-12-30",{"date":103,"type":104},"2026-01-05","ACTUAL",{"date":106,"type":104},"2022-07-13",{"date":108,"type":87},"2026-12",{"name":5,"class":6},1]