NCT07327216

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Affiliated Hospital of Guangdong Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

• Nasopharyngeal Carcinoma (NPC)

Interventions

Type	Name	Description
DRUG	Sapylin	Atomized inhalation, 1 KE/time, QD from day 1 of CCRT until the end of radiotherapy.
DRUG	Dexamethasone	Dexamethasone (10 mg per administration) via atomized inhalation once daily (QD).
COMBINATION_PRODUCT	CCRT with Cisplatin	Patients receive cisplatin-based CCRT: cisplatin 80-100mg/m2, Q3W, three times during CCRT. Radiation dose: PTVnx: 69.96Gy/33F, PTV1: 60.06Gy/33F, PTV2: 54.12Gy/33F.

Timeline

• Start date: 2022-08-15
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2026-01-08
• Last updated: 2026-03-04

Locations

1 site across 1 country: China