Sapylin versus inhaled dexamethasone to prevent painful mouth sores during chemoradiation for nasopharyngeal cancer

Efficacy and Safety of Sapylin Versus Dexamethasone Atomized Inhalation for Concurrent Chemoradiotherapy-Induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma: A Randomized, Parallel, Non-inferiority Clinical Trial

This trial will test whether Sapylin given as an inhaled spray works better than inhaled dexamethasone at preventing or reducing radiation-induced mouth sores in adults with stage III–IVA nasopharyngeal cancer receiving concurrent chemoradiation with cisplatin.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Affiliated Hospital of Guangdong Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Radiation
• Locations: 1 site (Zhanjiang, Guangdong)
• Trial ID: NCT07327216 on ClinicalTrials.gov

What this trial studies

This phase 3 interventional trial compares atomized Sapylin with inhaled dexamethasone administered alongside standard cisplatin-based concurrent chemoradiation in patients with stage III–IVA nasopharyngeal carcinoma. Eligible participants are 18–75 years old with good performance status, intact baseline oral mucosa, no prior cancer therapy, and adequate blood, liver, and kidney function. Treatments are given during the course of chemoradiation and the study will track the incidence and severity of radiation-induced oral mucositis and the ability of patients to complete planned therapy. The single-site trial is being conducted at the Affiliated Hospital of Guangdong Medical University in Zhanjiang, Guangdong, China.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–75 with newly diagnosed stage III–IVA nasopharyngeal carcinoma, good performance status (KPS ≥80), normal oral mucosa before treatment, no prior cancer therapy, and adequate routine blood and biochemical parameters.

Not a fit: Patients with prior or concurrent other malignancies, distant metastasis, previous surgery/chemoradiotherapy/targeted or immunotherapy, a history of asthma or relevant allergic reactions, or those who do not meet the age or laboratory criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the intervention could reduce painful mouth sores, help patients complete chemoradiation on schedule, and improve overall treatment tolerance.

How similar studies have performed: Inhaled dexamethasone is used symptomatically and Sapylin delivered by atomized inhalation is a novel approach with only preliminary data and limited prior clinical evidence supporting its effectiveness for radiation-induced oral mucositis.

Eligibility criteria

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.

Where this trial is running

Zhanjiang, Guangdong

• Affiliated Hospital of Guangdong Medical University — Zhanjiang, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Haiqing Luo — Specialty of Head and Neck Oncology, Affiliated Hospital of Guangdong Medical University
• Study coordinator: Haiqing Luo, PhD

Conditions Nasopharyngeal Carcinoma; Nasopharyngeal carcinoma; radiation-induced oral mucositis; Sapylin; Dexamethasone; atomized inhalation