Traditional Chinese Medicine Oral Liquids and Mouthwashes for Radiation-induced Oral Mucositis in Head and Neck Cancer Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Incidence rate of severe oral mucositis (RTOG grade ≥ 3)
研究概览
简要总结
Evaluate the efficacy and safety of traditional Chinese medicine oral liquid and mouthwash in the treatment of radiotherapy induced oral mucositis in patients with head and neck malignancies
详细描述
The aim of this clinical trial is to evaluate the efficacy and safety of combining a traditional Chinese medicine (TCM) oral liquid with a mouthwash in reducing the incidence, duration, and severity of mild-to-moderate radiation-induced oral mucositis (RIOM). The study addresses two main questions: (1) whether the combined TCM oral liquid and mouthwash can effectively mitigate RIOM and lower the incidence of severe RIOM, and (2) whether their use is associated with adverse events in patients receiving radiotherapy.
Participants will begin treatment on the first day mild-to-moderate RIOM (RTOG grade 1-2) occurs during radiotherapy. They will take Qingying oral liquid four times daily and use a modified Da Huang-Huang Lian Xiexin mouthwash six times daily in combination, or receive a matching placebo. The treatment will continue until two weeks after radiotherapy. After each administration, patients must avoid eating, drinking, or performing oral hygiene for at least 1 hour to maximize mucosal contact time.
The trial will compare the intervention and placebo groups to determine the potential benefits of the combined regimen for managing RIOM.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
- •Age range: 18 to 65 years old (including 18 and 65 years old);
- •Eastern Cooperative Oncology Group performance status of ≤2;
- •Radiotherapy or concurrent chemoradiotherapy is required;
- •The main organ functions well;
- •Sign informed consent.
排除标准
- •Allergic constitution (such as those known to be allergic to two or more drugs);
- •Patients who plan to use drugs that can cause or worsen oral mucosal inflammation (such as anti EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.) after the start of radiotherapy;
- •Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
- •Poor oral hygiene and/or severe periodontal diseases;
- •History of head and neck radiotherapy;
- •Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
研究组 & 干预措施
Qingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash
干预措施: Qingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash (Drug)
Qingying oral liquid and modified Da Huang-Huang Lian Xiexin mouthwash
干预措施: radiotherapy (Radiation)
Placebo oral solution and mouthwash
干预措施: Placebo oral solution and mouthwash (Drug)
Placebo oral solution and mouthwash
干预措施: radiotherapy (Radiation)
结局指标
主要结局
Incidence rate of severe oral mucositis (RTOG grade ≥ 3)
时间窗: From the start of radiotherapy to 8 weeks after the end of radiotherapy. The evaluation period is approximately 14 to 14.5 weeks
The Radiation Therapy Oncology Group (RTOG) toxicity criteria were utilized to assess RIOM. Grade 0 shows no change from baseline; Grade 1 of RIOM is associated with mucosal erythema or hyperemiam,and may cause mild pain not requiring analgesics. Grade 2 presents with patchy mucositis that may produce an inflammatory serosanguinous discharge and may be associated with moderate pain; Grade 3 consists of confluent, fibrinous mucositis and may include severe pain requiring narcotics; Grade 4 is characterized by ulceration, hemorrhage, or necrosis. Grades 1 and 2 are considered mild to moderate, while grades 3 and 4 are classified as severe.
次要结局
- Duration of mild-to-moderate RIOM(From the start of radiotherapy to 8 weeks after the end of radiotherapy. The evaluation period is approximately 14 weeks and 14.5 weeks.)
- RIOM remission rates at 4 and 8 weeks after completion of radiotherapy(From the start of radiotherapy to 8 weeks after the end of radiotherapy. The evaluation period is approximately 14 weeks and 14.5 weeks.)
- Duration of oral mucositis (OM)(From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.)
- Weekly change in oropharyngeal pain scores (OMWQ)(From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.)
- Use of analgesics(From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.)
- Xerostomia(1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks); 4 weeks and 8 weeks after the end of radiotherapy.)
- European Organization for Research and Treatment of Cancer (EORTC) Head and Neck Cancer Module (EORTC QLQ-H&N35).(1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks) ; and and 4 weeks and 8 weeks after the end of radiotherapy.)
- Adverse events(From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks.)
研究者
Xingchen Peng
PhD, Professor
West China Hospital