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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: hqluo@126.com
• Phone: +8613729196345

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.