[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radiotherapy-induced-oral-mucositis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radiotherapy-induced-oral-mucositis":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,46,72,97,116],{"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":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100634768","phase-3-traditional-chinese-medicine-for-the-prevention-of-radiotherapy-induced-oral-mucositis-rtom-100634768",false,"NCT07543978","Traditional Chinese Medicine for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM)","Modified Dahuang Huanglian Xiexin Mouthwash for the Prevention of Radiotherapy-Induced Oral Mucositis (RTOM): A Multicenter, Randomized, Controlled Trial","Inclusion Criteria:\n\n1. Aged 18 to 70 years (inclusive) at the time of screening.\n2. Histologically confirmed squamous cell carcinoma of the nasopharynx, oral cavity, or oropharynx.\n3. Planned to receive radiotherapy.\n4. No prior history of radiotherapy to the head and neck region.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Adequate major organ function as defined by the following criteria (within 14 days prior to enrollment, without transfusion support):\n\n   Hemoglobin (Hb) ≥90 g\u002FL Absolute neutrophil count (ANC)≥1.5×10⁹\u002FL Platelet count (PLT) ≥80×10⁹\u002FL Total bilirubin (BIL) \\\u003C 1.25×upper limit of normal (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 2.5×ULN Serum creatinine (Cr)≤ULN, or calculated creatinine clearance (Cockcroft-Gault formula) \\> 50 mL\u002Fmin\n7. Signed written informed consent prior to any study-related procedures.\n8. Judged by the investigator to be able to comply with the study protocol.\n9. Negative pregnancy test (for women of childbearing potential) at screening.\n10. Willing and able to adhere to scheduled visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Pre-existing oral mucositis prior to the start of radiotherapy.\n2. Prior radiotherapy to the head and neck region.\n3. Major surgery within 3 weeks prior to enrollment.\n4. Uncontrolled cardiac conditions or symptoms, including but not limited to:\n\n   New York Heart Association (NYHA) class II or higher heart failure Unstable angina pectoris Myocardial infarction within 1 year prior to enrollment Clinically significant supraventricular or ventricular arrhythmia requiring intervention\n5. Use of topical (oral) or systemic corticosteroids within 1 week prior to enrollment.\n6. Active infection requiring systemic therapy.\n7. Known history of substance abuse, alcohol abuse, or drug addiction.\n8. Pregnancy or breastfeeding.\n9. Any other condition that, in the investigator's judgment, may interfere with the participant's ability to complete the study or compromise the collection of study data, including but not limited to serious concurrent illness (including psychiatric disorders) requiring concomitant treatment, severely abnormal laboratory values, or unfavorable family or social circumstances.","ALL","18 Years","70 Years",{"count":20,"type":21},156,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multicenter, randomized, controlled, prospective clinical trial designed to observe and evaluate the safety and efficacy of Modified Dahuang Huanglian Xiexin Mouthwash for the prevention of radiotherapy-induced oral mucositis (RTOM).\n\nParticipants will be randomly assigned to receive either the Modified Dahuang Huanglian Xiexin Mouthwash or Placebo Mouthwash. The study aims to assess the preventative effect on RTOM in patients undergoing radiotherapy.",[27,28,29,30],"Radiotherapy-Induced Oral Mucositis","Stomatitis","Oral Mucositis","Radiotherapy Side Effects",[27,32,28,29,33],"RTOM","Radiation Injury","NOT_YET_RECRUITING","2026-04-14",{"date":37,"type":38},"2026-04-22","ACTUAL",{"date":40,"type":21},"2026-04-30",{"date":42,"type":21},"2027-12-31",{"name":44,"class":45},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"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":58,"conditions":59,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100619065","phase-2-traditional-chinese-medicine-preparation-alleviates-radiotherapy-induced-oral-mucositis-in-head-and-neck-cancer-patients-100619065","NCT07339774","Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.","Chinese Herbal Oral Solution and Mouthwash Shorten the Duration of Severe Radiotherapy-induced Oral Mucositis in Patients With Head and Neck Malignancies.","Inclusion Criteria:\n\n1. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;\n2. Age range: 18 to 65 years old (including 18 and 65 years old);\n3. Eastern Cooperative Oncology Group performance status of ≤2;\n4. Radiotherapy or concurrent chemoradiotherapy is required;\n5. The main organ functions well;\n6. Sign informed consent.\n\nExclusion Criteria:\n\n1. Allergic constitution (such as those known to be allergic to two or more drugs);\n2. Patients who plan to use drugs that can cause or worsen oral mucosal inflammation (such as anti EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.) after the start of radiotherapy;\n3. Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;\n4. Poor oral hygiene and\u002For severe periodontal diseases;\n5. History of head and neck radiotherapy;\n6. Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).","65 Years",{"count":55,"type":21},128,[57],"PHASE2","Evaluate the effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors.",[60],"Radiotherapy-induced Oral Mucositis","RECRUITING","2026-03-21",{"date":64,"type":38},"2026-03-25",{"date":66,"type":21},"2026-03-30",{"date":68,"type":21},"2026-12-30",{"name":70,"class":45},"West China Hospital",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":71},"100590523","correlation-and-predictive-research-of-metal-elements-in-radiation-induced-oral-mucositis-100590523","NCT06968520","Correlation and Predictive Research of Metal Elements in Radiation-Induced Oral Mucositis","Correlation and Predictive Study of Metal Elements in Radiation-Induced Oral Mucositis: A Prospective, Longitudinal Cohort Study","Inclusion Criteria:\n\n1）Sign the informed consent form; 2) Confirmed by pathological biopsy as nasopharyngeal carcinoma or head and neck tumors; 3) Have indications for radiotherapy and voluntarily accept radiotherapy; 4) ECOG PS: 0\u002F1; 5) Age: 18-75 years old; 6) Laboratory tests confirm good organ function.\n\nExclusion Criteria:\n\n1. There are contraindications for radiotherapy;\n2. Combined with other tumors;\n3. Pathological sections could not be obtained;\n4. The patient has any serious concurrent diseases that may pose unacceptable risks or have a negative impact on trial compliance. For instance, unstable heart diseases requiring treatment, chronic hepatitis, kidney diseases with poor conditions, uncontrolled diabetes (fasting blood glucose greater than 1.5 × ULN), and mental disorders;\n5. The researcher judged that it was not suitable to participate in this study.","75 Years",{"count":81,"type":21},383,"OBSERVATIONAL","Radiotherapy is the main treatment method for head and neck tumors. However, almost all patients with head and neck tumors will develop acute inflammatory reactions such as Radiotherapy-Induced Oral Mucositis (RIOM) after receiving Radiotherapy, resulting in a decline in the quality of life of patients, hindering the smooth implementation of the treatment plan, reducing the therapeutic effect, and increasing the economic burden of patients. However, the current treatment strategies for RIOM focus on symptomatic treatment and have little impact on the course, severity and related complications of mucositis. Therefore, exploring effective strategies, predicting the incidence and severity of RIOM in patients, and providing prevention and treatment are the clinical bottlenecks and cutting-edge issues that urgently need to be solved in the current clinical practice of radiotherapy for head and neck tumors. Previous studies have shown that the steady-state of metallic elements may be closely related to the occurrence and development of RIOM. Therefore, we plan to conduct a prospective, single-center, observational study to further explore the correlation between metal elements and severe RIOM, analyze its predictive efficacy, and observe the dynamic changes of metal elements in radiotherapy.",[85,86,87,27],"Head and Neck Tumors","Metal","Copper","2025-05-05",{"date":90,"type":38},"2025-05-13",{"date":92,"type":38},"2025-04-24",{"date":94,"type":21},"2026-02-28",{"name":96,"class":45},"Nanfang Hospital, Southern Medical University",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":103,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":115,"locationsCount":71},"100575069","breathomics-in-the-diagnosis-and-prediction-of-radiotherapy-induced-oropharyngeal-mucositis-in-head-and-neck-tumors-100575069","NCT06767488","Breathomics in the Diagnosis and Prediction of Radiotherapy-Induced Oropharyngeal Mucositis in Head and Neck Tumors","Inclusion Criteria:\n\n* Voluntarily sign informed consent. Over 18 years of age. Histologically confirmed head and neck tumors, treated with radiotherapy or chemoradiotherapy.\n\nECOG PS Score: 0\u002F1\u002F2.\n\nExclusion Criteria:\n\n* Lung disease such as lung cancer, tuberculosis, and lung infections. Inhalation anesthesia within 3 months. Inhalation medication within 3 months. Postoperative laryngeal cancer. Concurrent serious uncontrolled medical conditions such as unstable heart disease requiring treatment, poorly controlled diabetes mellitus (fasting blood glucose \\> 1.5 x upper limit of normal).\n\nParticipation deemed inappropriate in the judgment of the investigator.",{"count":104,"type":21},375,"Radiotherapy-Induced Oropharyngeal Mucositis (RIOM) is one of the most distressing side effects for patients with head and neck tumors during radiotherapy, requiring clinical physicians to manage it according to the severity of mucositis to alleviate symptoms and improve quality of life. However, traditional diagnosis of RIOM overly relies on subjective evaluation, lacks early sensitivity, and existing biomarker diagnostic methods suffer from insufficient efficacy, invasiveness, and inconsistent results. This study aims to explore the diagnostic and predictive value of exhaled breathomics in RIOM of head and neck tumors. By collecting exhaled breath samples from head and neck tumor patients undergoing radiotherapy and analyzing volatile organic compounds (VOCs) using breath detection technology, we aim to develop and validate a non-invasive diagnostic and predictive model based on exhaled breathomics. The study will identify specific VOCs as potential biomarkers, providing new tools for early diagnosis, timely prediction, and personalized treatment of RIOM.",[85,107,108,60],"Breathomics","Volatile Organic Compounds","2025-01-08",{"date":111,"type":38},"2025-01-10",{"date":113,"type":38},"2024-12-06",{"date":40,"type":21},{"name":96,"class":45},{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":125,"conditions":126,"keywords":130,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":5},"100539705","plasma-saa1-levels-in-predicting-response-to-radiotherapy-induced-oral-mucositis-100539705","NCT06307314","Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis","A Prospective Cohort Study of Plasma SAA1 Levels in Predicting Response to Radiotherapy-induced Oral Mucositis","Inclusion Criteria:\n\n* Over 18 years of age.\n* Voluntarily sign informed consent.\n* The pathological diagnosis was nasopharyngeal carcinoma, head and neck tumor.\n* Need to be treated with radiotherapy.\n* ECOG PS Score: 0\u002F1.\n\nExclusion Criteria:\n\n* There are contraindications to radiotherapy.\n* Combined with other tumors.\n* Patients had any serious coexisting medical conditions that could pose an unacceptable risk or negatively affect trial adherence. For example, unstable heart disease requiring treatment, chronic hepatitis, kidney disease, poor disease status, uncontrolled diabetes (fasting blood glucose \\> 1.5 × ULN), and mental illness.\n* At the investigator's discretion, those who was not considered to be suitable for participation in the study.",{"count":124,"type":21},300,"Head and neck squamous cell carcinoma (SCC) is the sixth most common cancer worldwide, with more than 700,000 new cases and more than 350,000 deaths each year. At present, radiotherapy is an important measure to control the recurrence of head and neck tumors, but almost all patients with head and neck squamous cell carcinoma will have acute inflammatory reactions such as radiotherapy-induced oral mucositis (RIOM) after radiotherapy, which seriously affects the quality of life and radiotherapy efficacy of patients. Serum amyloid A1 (SAA1) is an acute phase protein associated with inflammation. Our previous basic research found that serum SAA1 expression levels can be used as biomarkers to assess the dose received by the receptor in the early stages of radiation damage. At the same time, we confirmed that the serum level of SAA1 in patients with nasopharyngeal carcinoma increased after radiotherapy. Therefore, we intend to conduct a prospective, multicenter, observational study to further explore the predictive power of plasma SAA1 levels for radiotherapy-induced oral mucositis, with a view to early screening and prevention of RIOM patients.",[127,128,60,129],"Nasopharyngeal Carcinoma","Head and Neck Cancer","Biomarker",[131,60,128,127],"SAA1","2024-03-06",{"date":134,"type":38},"2024-03-12",{"date":136,"type":38},"2024-02-01",{"date":138,"type":21},"2026-12-31",{"name":96,"class":45}]