A Multicenter, Single-Arm, Open-Label Intervention Trial with Historical Control to Explore the Effectiveness of Oral Honey Administration in Preventing Chemoradiotherapy-Induced Oral Mucositis in Pediatric and Adolescent Patients with Head and Neck Malignacies

未提供0 个研究点目标入组 20 人开始时间: 待定

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•Patients meeting all of the following criteria are eligible.
•Patients diagnosed with malignant tumors based on pathology and/or clinical findings
•Patients aged 1 year or older but under 20 years at the time of informed consent
•Patients scheduled to receive combined proton beam therapy and chemotherapy
•Patients whose initial radiation field includes directly visible oral mucosa (tongue, hard palate, buccal mucosa, gingiva, floor of mouth) and/or oropharyngeal mucosa (soft palate, palatine tonsils, posterior wall), and who are expected to receive a total dose of 36 Gy or more
•Patients who, after receiving sufficient explanation regarding participation in this trial, provided written consent of their own free will, based on full understanding, either personally or through a proxy

•Patients meeting any of the following criteria will be excluded from the study.
•Patients with an allergy to honey
•Patients with diabetes
•Other patients deemed unsuitable as subjects by the principal investigator (or co-investigator)

发起方

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