Actively Recruiting
Sapylin Versus Dexamethasone Inhalation for CCRT-Induced Oral Mucositis in Nasopharyngeal Carcinoma
Led by Affiliated Hospital of Guangdong Medical University · Updated on 2026-03-04
180
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 this way may enhance the effectiveness of chemotherapy and boost the body's immunity. The main purpose of this study is to determine the effect of Sapylin inhalation on the incidence and severity of RTOM, and to evaluate its safety and impact on the overall success of CCRT. By participating, you will help researchers find a high-efficiency, low-toxicity method to improve CCRT outcomes and manage RTOM for future NPC patients and specialists.
CONDITIONS
Official Title
Sapylin Versus Dexamethasone Inhalation for CCRT-Induced Oral Mucositis in Nasopharyngeal Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with stage III-IVa nasopharyngeal carcinoma using pathology
- No previous radiotherapy, chemotherapy, surgery, immunization, or targeted therapy
- Karnofsky Performance Status score of 80 or higher
- Oral mucosa is intact and normal before treatment
- Age between 18 and 75 years
- Willing to participate and able to provide informed consent in person
- Routine blood tests showing white blood cell count at least 4.0x10^9/L, hemoglobin at least 100 g/L, neutrophil count at least 1.5x10^9/L, and platelet count at least 100x10^9/L
- Biochemical tests showing total bilirubin no more than 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase no more than twice the upper limit of normal, and estimated glomerular filtration rate at least 60 mL/min
You will not qualify if you...
- Having other malignant tumors currently or in the past, or distant metastasis during treatment
- Previous surgery, chemoradiotherapy, or targeted immunotherapy
- History of asthma, rash, urticaria, or other allergic diseases
- History of autoimmune diseases, connective tissue diseases, or diabetes affecting oral mucosa healing
- Heart disease, kidney disease, or acute infections that seriously risk safety or study completion
- Pregnant, breastfeeding, or planning pregnancy during the study
- Known allergies to the study drugs or penicillin
- Mental or nervous system diseases or poor compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Actively Recruiting
Research Team
H
Haiqing Luo, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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