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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Incidence of Radiation-Induced Oral Mucositis (RIOM)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Sapylin Group
CCRT combined with Sapylin atomized inhalation (1 KE/time, QD from day 1 till the end of radiotherapy).
干预措施: Sapylin (Drug)
Sapylin Group
CCRT combined with Sapylin atomized inhalation (1 KE/time, QD from day 1 till the end of radiotherapy).
干预措施: CCRT with Cisplatin (Combination Product)
Dexamethasone Group
CCRT combined with Dexamethasone atomized inhalation (10 mg/time, QD from day 1 till the end of radiotherapy).
干预措施: Dexamethasone (Drug)
Dexamethasone Group
CCRT combined with Dexamethasone atomized inhalation (10 mg/time, QD from day 1 till the end of radiotherapy).
干预措施: CCRT with Cisplatin (Combination Product)
结局指标
主要结局
Incidence of Radiation-Induced Oral Mucositis (RIOM)
时间窗: From the start of Concurrent Chemoradiotherapy (CCRT) through the completion of radiotherapy, assessed weekly for approximately 7 weeks.
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.
Severity of Radiation-Induced Oral Mucositis (RIOM)
时间窗: From Week 1 of Concurrent Chemoradiotherapy (CCRT) until the end of Radiotherapy (Week 7).
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.
次要结局
- Duration of Radiation-Induced Oral Mucositis (RIOM)(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(Measured at the end of the concurrent chemoradiotherapy (CCRT) regimen (Week 7).)
- Incidence and Severity of Adverse Events (AEs)(Daily recording during treatment; Follow-up every 3 months for one year after treatment completion.)
- Change in Body Mass Index (BMI)(Baseline (before CCRT starts) and at the end of treatment (End of Radiotherapy, approximately Week 7).)