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

NCT07327216 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-03-04

No results posted yet for this study

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

DRUG

Dexamethasone

Dexamethasone (10 mg per administration) via atomized inhalation once daily (QD).

DRUG

Sapylin

Atomized inhalation, 1 KE/time, QD from day 1 of CCRT until the end of radiotherapy.

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.

Sponsors & Collaborators

  • Affiliated Hospital of Guangdong Medical University

    lead OTHER

Principal Investigators

  • Haiqing Luo · Specialty of Head and Neck Oncology, Affiliated Hospital of Guangdong Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2026-07-01
Completion
2027-07-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07327216 on ClinicalTrials.gov