A Randomized Controlled Study of Houyanqing Oral Liquid Combined With Conventional Treatment Versus Conventional Treatment Alone for Preventing and Treating Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 386
- 试验地点
- 16
- 主要终点
- Incidence of ≥ Grade II radiation-induced oral mucositis
研究概览
简要总结
To explore the efficacy of Houyanqing Oral Liquid combined with conventional treatment in preventing and treating radiation-induced oral mucositis, so as to improve the quality of life of nasopharyngeal carcinoma patients received radiotherapy.
详细描述
Nasopharyngeal carcinoma (NPC) is a highly prevalent malignant tumor in China. Radical radiotherapy serves as its core treatment modality, yet radiation-induced oral mucositis (RIOM) is the most common adverse reaction of radiotherapy, with an incidence rate as high as 85%-100%, among which 34% of patients develop grade 3-4 mucositis. RIOM can cause oral pain, ulcers, and dysphagia, which not only severely reduce patients' quality of life but also may lead to radiotherapy interruption, increased infection risk, and elevated treatment costs. Therefore, the prevention and treatment of RIOM are of great significance.
At present, conventional clinical prevention and treatment methods include oral hygiene maintenance, epithelial repair-promoting drugs (e.g., recombinant human epidermal growth factor spray, sodium aescinate for injection), and symptomatic supportive care, but there is no universally recognized standard regimen. Houyanqing Oral Liquid is a traditional Chinese medicine preparation composed of Achyranthes aspera L., Kalimeris indica (L.) Sch.-Bip., Plantago asiatica L., and Carpesium abrotanoides L. It possesses the effects of clearing heat and detoxifying, relieving sore throat and pain. Previous studies have confirmed that it exhibits significant efficacy in anti-inflammation, bacteriostasis, and mucosal injury repair, which can shorten the course of oral ulcers and reduce the recurrence rate.
This study intends to conduct a randomized controlled clinical trial to compare the efficacy of Houyanqing Oral Liquid combined with conventional treatment versus conventional treatment alone in preventing RIOM in NPC patients. It aims to verify the advantages of the combined regimen in reducing the incidence of ≥ grade II RIOM, delaying the onset time, alleviating the severity of injury, and improving patients' quality of life, so as to provide a more effective and safe prevention and treatment strategy for RIOM in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (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
- •Staged as Stage I-IV according to the 9th edition of the TNM Classification of Malignant Tumors formulated by the American Joint Committee on Cancer (AJCC) and the Union for International Cancer Control (UICC);
- •Age: 18 to 75 years old;
- •Karnofsky Performance Status (KPS) score ≥ 80 before treatment;
- •No oral diseases (such as oral mucositis or salivary gland damage) before radiotherapy;
- •Requiring radical radiotherapy;
- •The patient has signed the informed consent form and is willing and able to comply with the study's follow-up visits, treatment plan, laboratory tests, and other research procedures.
排除标准
- •Patients with confirmed tumor recurrence, distant tumor metastasis, or who have received other anti-tumor treatments;
- •Previous history of head and neck radiotherapy;
- •Known allergy to the drugs used in this study (Houyanqing Oral Liquid, any conventional treatment drugs);
- •Local use of Houyanqing Oral Liquid, Recombinant Human Epidermal Growth Factor (rhEGF) Topical Solution, Vitamin B12 Solution, or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) mouthwash in the oral cavity within one month before enrollment;
- •Comorbidities requiring long-term treatment with immunosuppressive drugs, or systemic/local use of corticosteroids at immunosuppressive doses before enrollment;
- •HIV-positive patients;
- •Pregnant women or lactating women;
- •Patients with severe mental illnesses;
- •Patients with severe cardio-cerebrovascular diseases, endocrine disorders, infectious diseases, or other tumors.
研究组 & 干预措施
Houyanqing Oral Liquid combined with Conventional Treatment
This arm involves Houyanqing Oral Liquid combined with conventional treatment for preventing radiation-induced oral mucositis (RIOM) in nasopharyngeal carcinoma patients receiving radical radiotherapy. Specific interventions include: 1) Houyanqing Oral Liquid administration before and during radiotherapy; 2) Conventional treatment (same as the control arm): oral hygiene management, epithelial repair promotion, and symptomatic support therapy; 3) Radical radiotherapy (conventional fractionation). The aim is to evaluate the effect of this combined regimen on reducing RIOM severity.
干预措施: Houyanqing Oral Liquid (Drug)
Houyanqing Oral Liquid combined with Conventional Treatment
This arm involves Houyanqing Oral Liquid combined with conventional treatment for preventing radiation-induced oral mucositis (RIOM) in nasopharyngeal carcinoma patients receiving radical radiotherapy. Specific interventions include: 1) Houyanqing Oral Liquid administration before and during radiotherapy; 2) Conventional treatment (same as the control arm): oral hygiene management, epithelial repair promotion, and symptomatic support therapy; 3) Radical radiotherapy (conventional fractionation). The aim is to evaluate the effect of this combined regimen on reducing RIOM severity.
干预措施: Conventional Treatment for Radiation-Induced Oral Mucositis (Other)
Conventional Treatment
This arm consists of conventional treatment for preventing radiation-induced oral mucositis (RIOM) in nasopharyngeal carcinoma patients undergoing radical radiotherapy. Specific interventions include: 1) Oral hygiene management; 2) Epithelial repair promotion; 3) Symptomatic support . Patients in this arm will receive radical radiotherapy (conventional fractionation) but will not be administered Houyanqing Oral Liquid.
干预措施: Conventional Treatment for Radiation-Induced Oral Mucositis (Other)
结局指标
主要结局
Incidence of ≥ Grade II radiation-induced oral mucositis
时间窗: From the start of radical radiotherapy to the 3 months after the completion of radiotherapy
The proportion of patients in the group who develop Grade II or above radiation-induced oral mucositis from the start of radiotherapy. The degree of oral mucosal damage is evaluated according to the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) diagnostic and grading criteria for radiation-induced oral mucositis.
次要结局
- Time to onset of Grade II or above radiation-induced oral mucositis(From the start of radical radiotherapy to the 3 months after the completion of radiotherapy.)
- Cumulative radiotherapy dose at onset of Grade II or above radiation-induced oral mucositis(From the start of radical radiotherapy to the 3 months after the completion of radiotherapy.)
- Remission rate of Grade II or above radiation-induced oral mucositis(From the first occurrence of Grade II or above radiation-induced oral mucositis to 3 months after the completion of radiotherapy)
- Complete remission rate of radiation-induced oral mucositis(From the first occurrence of Grade II or above radiation-induced oral mucositis to 3 months after the completion of radiotherapy)
- Remission time of Grade II or above radiation-induced oral mucositis(From the first occurrence of Grade II or above radiation-induced oral mucositis to 3 months after the completion of radiotherapy.)
- Complete remission time of radiation-induced oral mucositis(From the first occurrence of Grade II or above radiation-induced oral mucositis to 3 months after the completion of radiotherapy.)
研究者
Ming-Yuan Chen
Professor
Sun Yat-sen University