[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634380":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":30,"locations":26,"responsibleParty":36,"collaborators":26,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":26,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":26,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":65,"whyStopped":26,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":26},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Kangfu Spray plus Standard Oral Care","EXPERIMENTAL","Participants receive Kangfu Spray prophylaxis in addition to standard oral care, oral hygiene education, and supportive care during intensity-modulated radiotherapy (IMRT), with or without concurrent platinum-based chemotherapy.",[13],"Device: Kangfu Spray",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Oral Care","ACTIVE_COMPARATOR","Participants receive standard oral care, including oral hygiene education, routine oral care, and symptom-directed supportive treatment as needed during IMRT, with or without concurrent platinum-based chemotherapy.",[19],"Other: Standard Oral Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Kangfu Spray","Standard oral care includes oral hygiene education, routine oral care, and symptom-directed supportive treatment as needed.",[9],null,{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Standard oral care includes oral hygiene education, routine oral care, and symptom-directed supportive treatment as needed during IMRT.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":26,"email":35},"Ye Zhang, MD","CONTACT","010 8778 8709","Drzye1983@163.com",{"type":37,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","YE ZHANG","Principal Investigator","100634380","a-phase-ii-prospective-open-label-randomized-multicenter-study-of-kangfu-spray-for-the-prevention-of-radiation-induced-oral-mucositis-in-patients-with-oral-malignancies-receiving-intensity-modulated-radiotherapy-100634380",false,"NCT07538934","A Phase II Prospective, Open-Label, Randomized, Multicenter Study of Kangfu Spray for the Prevention of Radiation-Induced Oral Mucositis in Patients With Oral Malignancies Receiving Intensity-Modulated Radiotherapy","A Prospective, Open-Label, Randomized, Controlled, Multicenter Phase II Study of Kangfu Spray for the Prevention of Radiation-Induced Oral Mucositis in Patients With Oral Malignancies Undergoing Intensity-Modulated Radiotherapy","Inclusion Criteria:\n\n* Histologically confirmed oral malignancy.\n* Age 18 to 80 years.\n* Karnofsky Performance Status (KPS) score \\>=70.\n* Planned to receive definitive or postoperative adjuvant intensity-modulated radiotherapy (IMRT), with or without concurrent chemoradiotherapy, after multidisciplinary team evaluation.\n* Adequate organ function, including white blood cell count \\>=2.0 x 10\\^9\u002FL, absolute neutrophil count \\>=1.0 x 10\\^9\u002FL, platelet count \\>=80 x 10\\^9\u002FL, hemoglobin \\>=90 g\u002FL, serum creatinine \\\u003C=1.5 x upper limit of normal (ULN) or creatinine clearance \\>=50 mL\u002Fmin, total bilirubin \\\u003C=1.5 x ULN, and AST\u002FALT \\\u003C=2.5 x ULN.\n* Able to understand and comply with study procedures.\n* Written informed consent provided.\n\nExclusion Criteria:\n\n* Known allergy to Kangfu Spray or severe allergic predisposition.\n* Uncontrolled immune-related oral mucosal disease or prior related immune mucosal disease.\n* Pregnancy or breastfeeding.\n* Prior radiotherapy to the head and neck region.\n* Any severe concomitant disease or condition that, in the investigator's judgment, makes the participant unsuitable for participation.","ALL","18 Years","80 Years",{"count":51,"type":52},140,"ESTIMATED","INTERVENTIONAL",[55],"NA","This is a prospective, open-label, randomized, controlled, multicenter phase II study evaluating the efficacy and safety of Kangfu Spray for the prevention of radiation-induced oral mucositis in patients with histologically confirmed oral malignancies receiving intensity-modulated radiotherapy (IMRT), with or without concurrent platinum-based chemotherapy.\n\nEligible participants will undergo definitive or postoperative adjuvant IMRT according to multidisciplinary team recommendations. Participants in the experimental group will receive Kangfu Spray prophylactically from the first day of radiotherapy until completion of radiotherapy, in addition to standard oral care. The primary endpoint is the incidence of severe radiation-induced oral mucositis, defined as World Health Organization (WHO) grade 3 or higher. Secondary endpoints include time to onset and duration of severe oral mucositis, incidence and duration of any oral mucositis, oral ulcer and pain scores, radiotherapy interruption, opioid analgesic use, nutritional indicators, quality of life, and safety. Exploratory analyses will evaluate lymphocytes, inflammatory factors, and microbiota in blood and saliva.",[58,59],"Radiation-induced Oral Mucositis","Oral Malignancy",[23,61,62,63,64],"radiation-induced oral mucositis","oral cancer","chemoradiotherapy","oral mucositis prevention","NOT_YET_RECRUITING","2026-04-13",{"date":68,"type":69},"2026-04-20","ACTUAL",{"date":71,"type":52},"2026-07-01",{"date":73,"type":52},"2029-10-01",{"name":38,"class":6}]