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Sapylin Versus Dexamethasone Inhalation for CCRT-Induced Oral Mucositis in Nasopharyngeal Carcinoma

RecruitingPhase 3Ages 18 Years - 75 YearsAllAffiliated Hospital of Guangdong Medical Universi…
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In plain words

What the trial is, and whether it could suit you

Radiation therapy is the main treatment for nasopharyngeal carcinoma (NPC), and standard care for advanced NPC often includes combination chemotherapy and radiation (CCRT). However, many patients experience serious side effects, such as painful mouth sores (Radiation-Induced Oral Mucositis, RTOM). These side effects can be so severe that they lower a patient's ability to adhere to treatment, potentially making the CCRT less effective. Studies have shown that a significant number of patients stop treatment early due to this toxicity. Current clinical guidelines from organizations like MASCC/ISOO and ESMO agree that preventing RTOM is crucial, but there is currently no specific drug that works for everyone. This study aims to investigate a new approach: using Sapylin, a biological immune regulator, delivered through an atomized inhaler. Preliminary research suggests Sapylin delivered thi

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
1. Inclusion Criteria: * Stage III-IVa NPC (AJCC 8th edition) diagnosed via pathology in a tertiary hospital; * No previous radiotherapy, chemotherapy, surgery, immunization, or targeted therapy; * Karnofsky Performance Status score ≥80; * Intact and normal oral mucosa before treatment; * Age 18-75 years; * Voluntary participation and provision of informed consent in person; * Routine blood examination: white blood cell count ≥4.0×109/L, hemoglobin ≥100g/L, neutrophil count ≥1.5×10\^9/L, and platelet count ≥100×10\^9/L; * Biochemical examination: total bilirubin ≤1.5×the upper limit of the normal range (ULN), alanine aminotransferase and aspartate aminotransferase ≤2×ULN, and estimated glomerular filtration rate ≥60 mL/min. 2. Exclusion Criteria: * With other malignant tumors in the past or present and/or distant metastasis during treatment; * Who have undergone surgery, chemoradiotherapy, and targeted immunotherapy; * With a history of asthma, rash, urticaria, and other allergic diseases; * With a history of autoimmune diseases, connective tissue diseases, and diabetes mellitus that significantly affect the healing of the oral mucosa; * With concomitant diseases, such as heart disease, kidney disease, and acute infectious diseases, which are judged by the investigator to seriously endanger the safety of patients or affect the completion of the study; * Who are breastfeeding, pregnant, or planning to become pregnant during the study; * With known allergies to the therapeutic agents and penicillin used in the trial; * Mental or nervous system diseases or poor compliance.
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What it tests

  • Sapylin
  • Dexamethasone
  • CCRT with Cisplatin
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Where

1 site
Affiliated Hospital of Guangdong Medical University
Zhanjiang, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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