[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100543349":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":47,"locations":53,"responsibleParty":69,"collaborators":25,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":25,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":25,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":56,"whyStopped":25,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Mansoura University","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Control arm","Standard Care",[12],"Drug: Institutional standard care",{"label":14,"type":15,"description":16,"interventionNames":17},"Interventional arm","ACTIVE_COMPARATOR","Standard Care plus NAC",[18],"Drug: N-Acetyl-Cysteine with Institutional standard care",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","N-Acetyl-Cysteine with Institutional standard care","A potent antioxidant and anti-inflammatory drug (A precursor of the endogenous antioxidant glutathione)",[14],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Institutional standard care","Benzydamine Mouthwash",[9],[31,35,38,41,44],{"name":32,"affiliation":33,"role":34},"Mohamed el-Husseiny shams, Professor","Department of Clinical pharmacy and Pharmacy practice, Faculty of Pharmacy, Mansoura University","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":33,"role":37},"Noha Mansour, phD","STUDY_DIRECTOR",{"name":39,"affiliation":40,"role":37},"Rasha Mohamed Abd-Ellatif, Professor","Center of Clinical Oncology and nuclear medicine, Faculty of Medicine, Mansoura University",{"name":42,"affiliation":43,"role":37},"Fatma Gharib Khirallah, Associate Professor","Center of Clinical Oncology and nuclear medicine, Faculty of Medicine, Tanta University",{"name":45,"affiliation":46,"role":37},"Mohamed Awad Ebrahim, Professor","Center of Medical Oncology and Adult BMT, Faculty of Medicine, Mansoura University.",[48],{"name":49,"role":50,"phone":51,"phoneExt":25,"email":52},"Reem Abou-Elezz, BSc","CONTACT","+201065396455","reemabouelezz@mans.edu.eg",[54],{"facility":55,"status":56,"city":57,"state":25,"zip":25,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Clinical Oncology and Nuclear Medicine of Mansoura University Hospital","RECRUITING","Al Mansurah","Egypt","EG",{"type":61,"coordinates":62},"Point",[63,64],31.38069,31.03637,{"lat":64,"lon":63},[67],{"name":68,"role":50,"phone":25,"phoneExt":25,"email":25},"Rasha Abd-Ellatif, Professor",{"type":34,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Noha Mansour","Lecturer of Clinical Pharmacy and Pharmacy Practice","100543349","phase-2-efficacy-of-n-acetylcysteine-in-preventing-radiotherapy-induced-oral-mucositis-in-head-and-neck-cancer-patients-100543349",false,"NCT06354712","Efficacy of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.","Clinical Study Evaluating the Efficacy and Safety of N-acetylcysteine in Preventing Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients.","Inclusion Criteria:\n\n1. Adults \\>18 years diagnosed with squamous cell carcinoma of the head and neck scheduled to receive curative radiotherapy (Primary or postoperative) of at least 50 Gy with or without concurrent chemotherapy.\n2. Individuals with healthy mucosa.\n3. Adequate bone marrow function (Hemoglobin level ≥10 g\u002FdL, platelet count ≥75 × 103\u002Fmicroliter, and absolute neutrophil count ≥1.5 × 103\u002Fmicroliter).\n4. Patients with ECOG performance ≤2\n\nExclusion Criteria:\n\n1. History of chemotherapy or radiotherapy.\n2. Signs of systemic infections.\n3. Pregnant and lactating women.\n4. Individuals receiving systemic analgesics.\n5. Liver disorders and renal failure with eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2 (by the MDRD equation).\n6. Inability to follow instructions and complete the questionnaires.",true,"ALL","18 Years","80 Years",{"count":84,"type":85},50,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","A prospective, randomized, controlled, parallel clinical trial will be conducted at Clinical Oncology and Nuclear Medicine Center at Mansoura University Hospital to assess the efficacy of N-acetylcysteine in the prevention of radiotherapy induced oral mucositis in Head and Neck cancer patients.",[91],"Oral Mucositis (Ulcerative) Due to Radiation",[93],"Oral Mucositis, Radiotherapy, N-acetylcysteine","2025-01-14",{"date":96,"type":97},"2025-01-15","ACTUAL",{"date":99,"type":97},"2024-04-04",{"date":101,"type":85},"2025-03-01",{"name":5,"class":6},1]