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

Affiliated Hospital of Guangdong Medical University

Status and phase: Enrolling; Phase 3

Conditions: Nasopharyngeal Carcinoma (NPC)

Treatments: Drug: Sapylin; Combination Product: CCRT with Cisplatin; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT07327216

PJKT2022-066

Details and patient eligibility

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 2 patient groups

Sapylin Group

Experimental group

Description:

CCRT combined with Sapylin atomized inhalation (1 KE/time, QD from day 1 till the end of radiotherapy).

Treatment:

Combination Product: CCRT with Cisplatin

Drug: Sapylin

Dexamethasone Group

Active Comparator group

Description:

CCRT combined with Dexamethasone atomized inhalation (10 mg/time, QD from day 1 till the end of radiotherapy).

Treatment:

Combination Product: CCRT with Cisplatin

Drug: Dexamethasone