[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oral-mucositis-ulcerative-due-to-radiation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oral-mucositis-ulcerative-due-to-radiation":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100636596","phase-2-taurine-for-the-prevention-and-treatment-of-radiation-induced-oral-mucositis-in-patients-with-nasopharyngeal-carcinoma-100636596",false,"NCT07567742","Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma","Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma: a Single-center, Open-label, Randomized Phase 2 Clinical Trial","Inclusion Criteria:\n\n1. Age 18-70 years.\n2. Histologically confirmed newly diagnosed non-keratinizing nasopharyngeal carcinoma (WHO classification).\n3. Non-metastatic nasopharyngeal carcinoma (Stage I-III) according to the AJCC 9th edition staging system.\n4. Scheduled to receive radical intensity-modulated radiotherapy (IMRT).\n5. No prior history of anti-cancer treatment.\n6. ECOG performance status 0-1; adequate organ function within 2 weeks before enrollment; Hematology: hemoglobin \\> 90 g\u002FL; absolute neutrophil count \\> 1.5×10⁹\u002FL; platelet count \\> 100×10⁹\u002FL. Biochemistry: total bilirubin ≤ 1.5×ULN; ALT, AST ≤ 2.5×ULN; ALP ≤ 2.5×ULN; creatinine clearance ≥ 50 mL\u002Fmin.\n7. For patients with abnormal ECG or prior cardiovascular disease, additional cardiac function tests and echocardiography must be normal.\n8. Provided written informed consent and willing to comply with study visits, treatment, laboratory tests, and other protocol requirements.\n\nExclusion Criteria:\n\n1. Known intolerance or hypersensitivity to taurine or its excipients.\n2. Conditions that interfere with oral drug administration (e.g., dysphagia, chronic diarrhea, intestinal obstruction).\n3. Prior history of malignant tumor.\n4. Pregnant or lactating women. (Pregnancy testing is required for women of childbearing potential; effective contraception must be used during treatment.)\n5. History or presence of severe oral ulcers, oral diseases, or salivary gland diseases.\n6. Unwilling to stop smoking, drinking alcohol, or chewing betel nut.\n7. Presence of severe active comorbidities.\n8. Severe dysfunction of heart, brain, lung, or other vital organs.\n9. Active infection requiring treatment; long-term use of immunosuppressive agents; psychiatric disorders.\n10. Unable to complete radiotherapy or likely to delay radiotherapy for more than 1 week due to subjective factors.\n11. Any other condition deemed inappropriate by the investigator.","ALL","18 Years","70 Years",{"count":20,"type":21},130,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This clinical trial aims to understand whether taurine can prevent and reduce severe radiation-induced oral mucositis in patients with nasopharyngeal carcinoma undergoing radiotherapy.",[27,28],"Oral Mucositis (Ulcerative) Due to Radiation","Nasopharyngeal Carcinoma (NPC)",[30,31,32],"Radiation-induced Oral Mucositis","Nasopharyngeal Carcinoma","Taurine","NOT_YET_RECRUITING","2026-04-30",{"date":36,"type":37},"2026-05-05","ACTUAL",{"date":39,"type":21},"2026-05-06",{"date":41,"type":21},"2029-03-30",{"name":43,"class":44},"Sun Yat-sen University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":45},"100616979","phase-2-aerosolized-mesenchymal-stem-cell-derived-exosomes-for-the-prevention-and-treatment-of-radiation-induced-oral-mucositis-100616979","NCT07312656","Aerosolized Mesenchymal Stem Cell-Derived Exosomes for the Prevention and Treatment of Radiation-Induced Oral Mucositis","Aerosolized Mesenchymal Stem Cell-Derived Exosomes for the Prevention and Treatment of Radiation-Induced Oral Mucositis: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed malignant tumor of the head and neck;\n2. Age 18-75 years;\n3. Scheduled to receive radical radiotherapy with a total planned dose of ≥60 Gy, with radiation fields including the oral cavity and\u002For oropharynx;\n4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 and a life expectancy of ≥6 months.\n5. White blood cell≥3.0×10\\^9\u002FL, hemoglobin≥ 90 g\u002FL, platelet (PLT)≥ 100x10\\^9\u002F L\n6. Transaminases≤2.5 times the upper limit of normal, total bilirubin ≤1.5 times the upper limit of normal;\n7. Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL\u002Fmin;\n8. Cardiac: Electrocardiogram (ECG) without clinically significant abnormalities;\n9. Intact oral mucosa before initiation of radiotherapy. Absence of active oral infections or severe periodontal disease before initiation of radiotherapy;\n10. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Previous radiotherapy to the head and neck region;\n2. Head and neck surgery within the preceding 4 weeks;\n3. Current participation in another clinical trial, or participation in another interventional study within the past 4 weeks;\n4. Significant cardiovascular disease, including unstable angina, myocardial infarction within the past 6 months, severe arrhythmia, or heart failure (NYHA Class III-IV);\n5. Severe hepatic or renal dysfunction, such as cirrhosis or chronic renal insufficiency (creatinine clearance \\\u003C30 mL\u002Fmin);\n6. Active systemic infection requiring antimicrobial therapy;\n7. Autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis) requiring ongoing immunosuppressive treatment;\n8. Severe psychiatric disorders that may impair the ability to provide informed consent or adhere to the study protocol;\n9. Using other oral mucosal protective agents or anti-inflammatory medications that cannot be discontinued. Long-term use of immunosuppressants or corticosteroids at a prednisone-equivalent dose \\>10 mg\u002Fday;\n10. Individuals unable to comprehend the study requirements or comply with study procedures;\n11. Any other condition that, in the judgment of the investigator, would render the patient unsuitable for participation in the study.","75 Years",{"count":55,"type":21},200,[24],"Radiation-induced oral mucositis (RIOM) is an inevitable acute complication in radiotherapy for head and neck malignancies, characterized by a complex pathogenesis involving multiple biological processes. According to the latest data from the International Agency for Research on Cancer (IARC), approximately 650,000 new cases of head and neck cancers are diagnosed globally each year, with about 70% of patients undergoing radiotherapy. RIOM develops through a multistep pathophysiological cascade, including initiation of mucosal injury, signaling amplification, inflammatory response, ulceration, and eventual healing. Ionizing radiation induces DNA damage in oral mucosal epithelial cells, triggering increased apoptosis. This cellular injury promotes the activation and release of pro-inflammatory mediators such as tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and interleukin-6 (IL-6), compromising the integrity of the mucosal barrier and ultimately leading to ulcer formation. Current clinical management of RIOM remains largely supportive, relying on oral hygiene, nutritional supplementation, and pain control, with no effective prophylactic agents available. Despite extensive research into potential interventions internationally, no drugs specifically approved by the FDA or NMPA for the prevention of RIOM have reached the market. This significant unmet clinical need calls for urgent scientific and therapeutic advancement. This study aims to evaluate the therapeutic efficacy and safety profile of aerosolized exosomes derived from mesenchymal stem cells in the prevention and treatment of radiation-induced oral mucositis in patients receiving radiotherapy for head and neck cancers. The ultimate objective is to establish a novel and effective therapeutic strategy for clinical application.",[27],"2025-12-17",{"date":61,"type":37},"2025-12-31",{"date":63,"type":21},"2026-01",{"date":65,"type":21},"2028-02",{"name":67,"class":44},"First Affiliated Hospital of Guangxi Medical University",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":75,"sex":16,"minAge":17,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":45},"100543349","phase-2-efficacy-of-n-acetylcysteine-in-preventing-radiotherapy-induced-oral-mucositis-in-head-and-neck-cancer-patients-100543349","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,"80 Years",{"count":78,"type":21},50,[24],"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.",[27],[83],"Oral Mucositis, Radiotherapy, N-acetylcysteine","RECRUITING","2025-01-14",{"date":87,"type":37},"2025-01-15",{"date":89,"type":37},"2024-04-04",{"date":91,"type":21},"2025-03-01",{"name":93,"class":44},"Mansoura University"]