[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488116":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":47,"collaborators":49,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":79,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Mucosa Innovations, S.L.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Acute and Chronic outcomes in radiotherapy treated HNC patients using XCM-OM118.","EXPERIMENTAL","Incidence and time to onset of severe oral mucositis during radiotherapy for HNC (Acute-phase 1).\n\nOral Mucositis in Head and Neck cancer patients using XCM-OM118 during radiotherapy was assessed by the clinician once weekly using the WHO scale and severity, if any, was graded from 0 to 4. Incidence and time to onset of severe oral mucositis were determined. Patient reported outcomes regarding their oral mucositis experience (pain and functional impairment) were collected through a questionnaire.\n\nQoL in HNC was assessed 6 months after radiotherapy and 1 month of use of XCM-OM118 (Chronic-phase 2).\n\nPatients who had completed oncological treatment six months earlier used the XCM-OM118 composition for one month. Quality of life was assessed at baseline and after the intervention using the University of Washington Quality of Life (UW-QOL) PROMs questionnaire, which measures domains including pain, appearance, and personal activity. Baseline scores were compared with final PROMs scores.",[13],"Other: XCM-OM118 Composition comprising olive oil, betaine and xylitol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"OTHER","XCM-OM118 Composition comprising olive oil, betaine and xylitol","Topical composition in the form of a gel and a mouthwash.",[9],null,[22],{"name":23,"affiliation":20,"role":24},"Beatriz Rodríguez-Vilaboa del Cura","STUDY_CHAIR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Jorge Rodríguez-Vilaboa","CONTACT","+34 629 288 597","jorge.vilaboa@mucosainnovations.com",[32],{"facility":33,"status":34,"city":35,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Mucosa Innovations S.L.","RECRUITING","Madrid","28023","Spain","ES",{"type":40,"coordinates":41},"Point",[42,43],-3.70256,40.4165,{"lat":43,"lon":42},[46],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":20},{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[50],{"name":51,"class":16},"HM Sanchinarro University Hospital","100488116","effect-of-a-novel-topical-composition-on-the-incidence-of-severe-oral-mucositis-in-head--neck-cancer-radiated-patients-and-quality-of-life-assessed-by-proms-100488116",false,"NCT05635929","Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs.","Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs. A Two Phases Study, Part of STOP OM PROJECT. Phase 2, Single Arm, Interventional, Longitudinal, Clinical Trial.","STOPOMP","Inclusion Criteria:\n\nAcute Phase\n\n* Patients diagnosed with Head \\& Neck cancer who will undergo radiotherapy (with or without concomitant chemotherapy)\n* Patients who are able to read, understand, and complete the questionnaire.\n* Patients over 18 years of age.\n\nChronic Phase\n\n* Patients who have completed radiotherapy treatment at least 6 months before study enrollement.\n* Patients who are able to read, understand, and complete the questionnaire.\n* Patients over 18 years of age.\n\nExclusion Criteria:\n\nAcute Phase\n\n* Patients who are unable to properly use the products.\n* Patients who do not consent to participate in the study.\n* Patients who were being treated for another type of cancer.\n\nChronic Phase\n\n* Patients using medications such as pilocarpine, cevimeline, etc., to treat xerostomia.\n* Patients who do not consent to participate in the study.","ALL","18 Years",{"count":63,"type":64},63,"ESTIMATED","INTERVENTIONAL",[67],"NA","The use of a novel topical mucosa composition (XCM-OM118) comprising 2-(trimethylazaniumyl) acetate; (2R,3R,4S)-pentane-1,2,3,4,5-pentol; Hexadecanoic acid; (9Z, 12Z)-octadeca-9,12-dienoic acid; octadecanoic acid; (Z)-hexadec-9-enoic acid; (Z)-octadec-9-enoic acid) delivered as a gel and a mouthwash is to be studied in regard to its effect on the incidence of severe oral mucositis in Head \\& Neck cancer radiated patients. Patient reported outcome measures seem to be an effective tool to obtain a greater knowledge of the physical and emotional state of patients, being used in this study to assess quality of life of Head \\& Neck cancer radiated patients.",[70,71,72,73,74,75,76,77,78],"Oral Mucositis","Quality of Life","Mucositis","Pain","Speech","Saliva","Radiation Toxicity","Chemotherapeutic Toxicity","Head and Neck Cancer",[70,80,81,73,82,83,84,85,86,78,87],"Cancer Therapy Toxic Effect","Cancer Support","Ulcers","Treatment Interruptions","Oral Mucosa","Radiotherapy","Chemotherapy","Severe Oral Mucositis","2026-04-10",{"date":90,"type":91},"2026-04-15","ACTUAL",{"date":93,"type":91},"2022-10-11",{"date":95,"type":64},"2027-03",{"name":5,"class":6},1]