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

Phase 3RecruitingNCT07327216

Affiliated Hospital of Guangdong Medical University180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

180

Conditions

Nasopharyngeal Carcinoma (NPC)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of Radiation-Induced Oral Mucositis (RIOM)

Incidence of RIOM is defined as the number of participants developing oral mucositis of any grade. Assessment is based on the World Health Organization (WHO) Oral Toxicity Scale. Scores range from 0 to 4 for ulceration, where higher scores indicate worse outcome.

Time frame: From the start of Concurrent Chemoradiotherapy (CCRT) through the completion of radiotherapy, assessed weekly for approximately 7 weeks.

Severity of Radiation-Induced Oral Mucositis (RIOM)

To compare the severity of RlOM between the Sapylin and Dexamethasone groups using the World Health Organization (WHO) Oral Toxicity Scale. Scores range from 0 to 4 for ulceration, where higher scores indicate worse outcome.

Time frame: From Week 1 of Concurrent Chemoradiotherapy (CCRT) until the end of Radiotherapy (Week 7).

Secondary Outcomes

Duration of Radiation-Induced Oral Mucositis (RIOM)

Time from the first diagnosis of RIOM (any grade) until the symptoms resolve to Grade 0 or return to baseline level.

Time frame: Daily assessment during CCRT, and up to 1 month after the completion of treatment (assessed up to 3 months).

Rate of Completion of Treatment Measures

Determined by comparing the actual dose and cycle count of Concurrent Chemoradiotherapy (CCRT) administered versus the planned total treatment regimen. Includes: 1) Actual dose divided by planned total dose (%); 2) Actual completed cycles divided by planned total cycles (%).

Time frame: Measured at the end of the concurrent chemoradiotherapy (CCRT) regimen (Week 7).

Incidence and Severity of Adverse Events (AEs)

All observed adverse events will be recorded and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame: Daily recording during treatment; Follow-up every 3 months for one year after treatment completion.

Change in Body Mass Index (BMI)

Change is defined as the difference between BMI (kg/m2) at the end of treatment and baseline BMI (Baseline BMI: before CCRT starts).

Time frame: Baseline (before CCRT starts) and at the end of treatment (End of Radiotherapy, approximately Week 7).