[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radiation-induced-xerostomia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radiation-induced-xerostomia":55},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100629556","sialendoscopy-versus-photobiomodulation-in-prevention-of-radiation-induced-xerostomia-100629556",false,"NCT07476209","Sialendoscopy Versus Photobiomodulation in Prevention of Radiation Induced Xerostomia","Sialendoscopic Management Versus Photobiomodulation in Prevention of Radiation-induced Xerostomia in Head and Neck Cancer Patients (Randomized Clinical Trial)","Inclusion Criteria:\n\n* Patients who are going to receive (IMRT) as a treatment of (HNC) either as postoperative (adjuvant) therapy or definitive therapy.\n* Patients who are planned to receive (RT) with parotid mean dose bilaterally not exceeding 25 Gy.\n* Males and females with an age not less than 18 years30\n\nExclusion Criteria:\n\n* Patients suffering from uncontrolled systemic diseases (such as diabetes, hypertension, cardiovascular, liver or renal dysfunction).\n* Patients with history of using drugs such as (pilocarpine ), oral humidifiers or herbs that prevent or treat xerostomia 2 months prior to study inclusion.\n* Patients with findings of any physical or mental abnormality which would interfere with or be affected by the study procedure.\n* Patients diagnosed with Sjögren's disease or other underlying systemic illness that is known to cause xerostomia.","ALL","18 Years",{"count":19,"type":20},42,"ESTIMATED","INTERVENTIONAL",[23],"NA","Radiation induced xerostomia (RIX) represents a common debilitating side effect for (RT), adversely affecting oral health and hindering head and neck cancer (HNC) patients' quality of life (QOL). To date, managing (RIX) is mainly symptomatic, while the only FDA-approved preventive therapeutic agent is Amifostine, with associated systemic toxicities. Sialendoscopic management is a minimally invasive technique that can help in restoring ductal patency, decreasing inflammation and improving salivary flow. Laser Photobiomodulation (PBM) is a noninvasive approach that enhances salivary gland function by stimulating cellular activity, increasing blood flow and attenuating oxidative stress.\n\nAim: The present study aims to evaluate and compare the efficacy of sialendoscopic management and photobiomodulation in managing (RIX) in (HNC) patients.\n\nMaterials and Methods: A randomized clinical trial will be carried out on 42 (HNC) patients. Directly prior to the first (RT) session, Group I (n= 14 patients) will receive sialendoscopic management. Group II (n=14 patients) will receive (PBM) sessions. Group III (n= 14 patients) will receive basic oral care (BOC). Xerostomia will be evaluated at baseline, at 3 weeks and after 8 weeks from the end of (RT), clinically using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and objectively using unstimulated salivary flow. Quality of life will be assessed using Multidisciplinary Salivary Gland Society (MSGS) questionnaire. Salivary amylase will be assessed at baseline and after 8 weeks from the end of (RT).",[26],"Radiation Induced Xerostomia","RECRUITING","2026-03-22",{"date":30,"type":31},"2026-03-25","ACTUAL",{"date":33,"type":20},"2026-04-01",{"date":35,"type":20},"2027-03-01",{"name":37,"class":38},"Alexandria University","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":39},"100595682","phase-1-a-randomized-controlled-trial-of-spermidine-for-the-prevention-of-radiation-induced-xerostomia-in-head-and-neck-squamous-cell-carcinoma-including-nasopharyngeal-carcinoma-100595682","NCT07035626","A Randomized Controlled Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia in Head and Neck Squamous Cell Carcinoma (Including Nasopharyngeal Carcinoma)","A Trial of Spermidine for the Prevention of Radiation-Induced Xerostomia","Inclusion Criteria:\n\n1. Patients with histopathologically confirmed head and neck squamous cell carcinoma (including nasopharyngeal carcinoma).\n2. Aged ≥18 years and ≤80 years.\n3. ECOG performance status score ≤2.\n4. Receiving radical radiotherapy or concurrent chemoradiotherapy with radiation dose \\>50 Gy, where: Both parotid glands receive an average dose ≥25 Gy; or one gland receives a dose ≥25 Gy and the other receives any dose.\n5. Blood routine parameters: hemoglobin ≥100 g\u002FL, platelets ≥80×10⁹\u002FL, white blood cell count ≥3.0×10⁹\u002FL, absolute neutrophil count ≥1.5×10⁹\u002FL.\n6. Signed informed consent form.\n\nExclusion Criteria:\n\n1. History of xerostomia, Sjögren's syndrome, or other known systemic diseases predisposing to dry mouth.\n2. Wheat allergy or gluten intolerance.\n3. Suspected or confirmed physical occlusion of bilateral salivary gland ducts.\n4. Prior history of head and neck radiotherapy.\n5. Use of any medications or herbal supplements that may affect salivary function within the past 30 days, or planned\u002Ffinal use during the study period (e.g., amifostine, cholinergic agonists \\[pilocarpine, cevimeline\\], certain β-adrenergic antagonists, anticholinergic drugs, or other known salivary function modifiers). If using saliva substitutes, patients must abstain from use for at least 24 hours prior to saliva and questionnaire data collection.\n6. Poor oral hygiene or severe periodontitis.\n7. Poor compliance.\n8. Pregnant or breastfeeding.\n9. Other patients deemed unsuitable by the investigator (e.g., concurrent severe comorbidities, mental disability, or severe emotional\u002Fpsychiatric disorders).","80 Years",{"count":49,"type":20},58,[51,52],"PHASE1","PHASE2","This study is a single-center, double-blind, randomized controlled clinical trial with placebo as the control, aiming to evaluate the effectiveness of spermidine in preventing radiation-induced xerostomia during radiotherapy for head and neck tumors (including nasopharyngeal carcinoma).",[55],"Radiation-induced Xerostomia",[57,58,59],"Head and Neck Malignant Tumors","Radiation-induced xerostomia","Spermidine","2025-06-24",{"date":62,"type":31},"2025-06-26",{"date":64,"type":31},"2025-06-25",{"date":66,"type":20},"2026-06-08",{"name":68,"class":38},"West China Hospital"]