[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radiotherapy-side-effects\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radiotherapy-side-effects":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,84,109],{"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":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100612359","mouthwash-temperature-and-oral-mucositis-in-head-and-neck-radiotherapy-100612359","NCT07252557","Mouthwash Temperature and Oral Mucositis in Head and Neck Radiotherapy","Effectiveness of Different Mouthwash Temperatures on Oral Mucositis Pain and Patient Comfort During Radiotherapy for Head and Neck Cancer: A Randomized Controlled Trial","CoolRinseHNC","Inclusion Criteria:\n\n* Histologically confirmed head and neck cancer (HNC) receiving radiotherapy for the first time, with or without concurrent chemotherapy.\n* Conscious, communicative, and able to perform the rinsing procedure and complete questionnaires.\n* Provided written informed consent prior to enrollment.\n\nExclusion Criteria:\n\n* Non-HNC diagnoses or radiotherapy to sites outside the oral\u002Foropharyngeal region.\n* Cognitive impairment or inability to complete the rinsing protocol.","20 Years","80 Years",{"count":57,"type":21},200,[59],"NA","This single-center randomized controlled trial evaluates the effects of cold (15-20°C) versus room-temperature (30-35°C) water gargling on oral mucositis severity, pain, and comfort in patients with head and neck cancer undergoing radiotherapy. Participants will rinse their mouth four times daily for 30-60 seconds over a 6-week radiotherapy course, with follow-up for two additional weeks. The study hypothesizes that cold-water rinsing can reduce the severity of radiation-induced oral mucositis (RTOM) and pain, improve oral comfort, and minimize treatment interruptions.",[62,63,64,65,30],"Head and Neck Cancer (H&Amp;Amp;N)","Radiation-induced Oral Mucositis","Supportive Care","Nursing Interventions",[67,68,69,70,64,71,72,73],"Head and Neck Cancer","Radiation-Induced Oral Mucositis","Water Temperature","Cold Water Rinse","Pain Management","Radiotherapy","Nursing Intervention","2025-11-24",{"date":76,"type":38},"2025-11-26",{"date":78,"type":21},"2026-01-01",{"date":80,"type":21},"2027-03-31",{"name":82,"class":45},"Chung Shan Medical University",1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100607516","phase-3-intranasal-corticosteroid-spray-for-preventing-otitis-media-with-effusion-after-radiotherapy-in-nasopharyngeal-carcinoma-100607516","NCT07189572","Intranasal Corticosteroid Spray for Preventing Otitis Media With Effusion After Radiotherapy in Nasopharyngeal Carcinoma","Efficacy of Intranasal Corticosteroid Spray in Preventing Otitis Media With Effusion After Radiotherapy for Nasopharyngeal Carcinoma: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial","Inclusion Criteria:\n\n* Pathologically confirmed nasopharyngeal carcinoma scheduled for curative intensity-modulated radiation therapy (IMRT), with or without concurrent chemotherapy.\n* Age between 18 and 75 years.\n* No previous history of head and neck radiotherapy.\n* Intact tympanic membranes bilaterally at baseline, with no history of middle ear surgery (including tympanostomy tube placement).\n* Willing to comply with all study procedures, including nasal spray use, audiological examinations, and follow-up visits.\n* No use of systemic or topical corticosteroids, antihistamines, or decongestants within 14 days prior to randomization.\n* All inclusion criteria must be met for participation\n\nExclusion Criteria:\n\n* Diagnosed with complete conductive hearing loss or ossicular chain fixation.\n* Scheduled to undergo tympanostomy tube placement, tympanotomy, or other middle ear surgery prior to randomization.\n* Unlikely to complete the 12-month follow-up (e.g., planned relocation, poor compliance).\n* Presence of respiratory conditions requiring treatment with nasal corticosteroids.\n* Known allergy or hypersensitivity to nasal corticosteroids (especially triamcinolone acetonide or its excipients).\n* History of severe mental illness, cognitive impairment, or substance abuse that may affect compliance.\n* Pregnant or lactating women, or women of childbearing potential unwilling to use effective contraception.\n* Participation in other investigational drug clinical trials within the past 3 months.\n* Deemed unsuitable for the trial by the investigator (e.g., severe septal deviation, chronic rhinosinusitis requiring systemic treatment, or poorly controlled diabetes).\n* Any subject who meets any of the above exclusion criteria at baseline will be excluded from the study.","75 Years",{"count":93,"type":21},168,[24],"This study focuses on a common side effect experienced by many patients after radiation therapy for nasopharyngeal cancer, which is a type of head and neck cancer. This side effect is called secretory otitis media (fluid buildup in the middle ear). It can cause a feeling of fullness in the ear and hearing loss. While procedures like ear tube placement can help, they can also lead to other problems like ear infections and drainage.\n\nRadiation treatment is thought to cause inflammation that disrupts the normal function of the tube connecting the ear to the throat (Eustachian tube), leading to this fluid buildup. A nasal spray containing a steroid medicine (triamcinolone acetonide) is already known to be safe and effective at reducing inflammation in the ear fluid of both children and adults. We believe that using this spray may also help prevent and improve this condition in nasopharyngeal cancer patients after radiation therapy.\n\nThe main goal of this study is to explore whether this nasal spray can effectively prevent or reduce fluid buildup in the ear following radiation therapy. We hope this non-invasive treatment will provide a new option to improve the quality of life for these patients.",[97,98,30,99,100],"Otitis Media","Otitis Media With Effusion After Nasopharyngeal Carcinoma","Radiotherapy Side Effect","Otitis Media With Effusion (OME)","2025-09-23",{"date":103,"type":38},"2025-09-29",{"date":105,"type":21},"2025-10",{"date":107,"type":21},"2027-10",{"name":44,"class":45},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":117,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":120,"phases":4,"briefSummary":121,"conditions":122,"keywords":127,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":141,"leadSponsor":143,"locationsCount":83},"100578807","gene-and-molecular-pathways-of-ozone-treatment-response-in-gynecological-tumor-patients-with-chronic-pelvic-pain-secondary-to-cancer-treatment-100578807","NCT06816095","Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Cancer Treatment","Gene and Molecular Pathway Characterization of the Response to Ozone Treatment in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Radio-chemotherapy","OzoGynEpigen","Inclusion Criteria:\n\n* Adult women (\\>=18 years old) with gynecological tumors treated with radiotherapy-chemotherapy.\n* Cancer disease is stable or in remission.\n* Life expectancy \\> = 6 months.\n* Patients included in the group of patients with pelvic pain must have a clinical, radiological, endoscopic, or histopathological diagnosis that their pain is not secondary to the oncological process.\n* Patients included in the group of patients with pelvic pain must have pain for \\>= 3 months duration, with an intensity \\>= 3 on the Visual Analog Scale (VAS), or classified as toxicity \\>= Grade-2 of the CTCAE v.5.0 of the National Cancer Institute of the USA.\n* Signed and dated informed consent specific to this study.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years old.\n* Severe psychiatric disorders.\n* Inability to complete the quality of life questionnaires.\n* Active neoplasia requiring recent initiation (\\\u003C 3 months) of systemic or local treatment.\n* Life expectancy (for any reason) \\\u003C 6 months.\n* Failure to meet all inclusion criteria","FEMALE",{"count":119,"type":21},40,"OBSERVATIONAL","Gynecological cancers, including those affecting the ovaries, uterus, and cervix, represent a significant health burden for women. While survival rates have improved, many women experience chronic pelvic pain secondary to cancer treatment, especially radiotherapy and chemotherapy. This treatment-induced pelvic pain can be of difficult management and significantly affects patients' quality of life.\n\nIn our experience, ozone therapy has emerged as a promising complementary treatment for pain relief in patients with chronic diseases, including side effects of cancer treatment. However, the genetic and epigenetic mechanisms influencing its effectiveness have not yet been thoroughly studied.\n\nThe aim of this prospective study is to analyze how ozone therapy modulates the expression of certain genes and its impact on epigenetic clocks, which could help predict pain response.",[123,124,30,125,126],"Chronic Pelvic Pain Syndrome (CPPS)","Radiation-Induced Disorder","Side Effect of Chemotherapy","Gynecological Cancers",[124,30,128,123,126,129,130,131,132,133,134,135],"Cancer survivors","gene expression","epigenetic clocks","side effects of cancer treatment","Toxicity of chemotherapy","Ozone therapy","Quality of Life","oxidative stress","RECRUITING","2025-02-10",{"date":139,"type":38},"2025-02-12",{"date":137,"type":38},{"date":142,"type":21},"2027-08-14",{"name":144,"class":45},"Bernardino Clavo, MD, PhD"]