Systematic Oral Care Education for Preventing Oral Complications in Patients Undergoing Radiotherapy for Head and Neck Malignancies: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The incidence of oral mucositis (OM)
研究概览
简要总结
A study on the efficacy of systematic oral health education for the prevention of oral-related complications caused by radiotherapy for head and neck malignant tumors
详细描述
The goal of this clinical trial is to investigate the efficacy of systematic oral health education for oral-related complications in patients with head and neck malignant tumors who receive radiotherapy. The main question it aims to answer is:
the efficacy of systematic oral health education for the prevention oral-related complications caused by radiotherapy for head and neck malignant tumors
Participants will:
be given systematic oral health education or routine oral health education be evaluated to learn the efficacy of systematic oral health education for the prevention of oral-related complications caused by radiotherapy for head and neck malignant tumors Researchers will compare systematic oral health education group with routine oral health education group to see if systematic oral health education has good efficacy for the prevention of oral-related complications caused by radiotherapy for head and neck malignant tumors.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with malignant tumors of the head and neck without metastasis
- •Age ≥18, ≤80 years old
- •ECOG_PS score ≤2
- •Receiving radiotherapy alone or concurrent radiotherapy with a radiation dose of >50 Gy
- •Signed informed consent form
排除标准
- •Patients with oral mucositis due to allergic reactions to certain foods, medications, or oral care products
- •Have a history of head and neck radiotherapy
- •Poor oral hygiene or severe periodontitis
- •Poor compliance
- •Other patients who, in the opinion of the investigator, are not suitable for participation in this study
研究组 & 干预措施
Experimental group
Systematic oral health education
干预措施: Systematic oral health education (Other)
Control group
Routine oral health education
干预措施: Routine oral health education (Other)
结局指标
主要结局
The incidence of oral mucositis (OM)
时间窗: 1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy
Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale(grade 1-5); Higher grade indicates more severe symptoms
次要结局
- The time to onset of severe oral mucositis (SOM) (WHO grade ≥3)(1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy)
- The duration of severe oral mucositis (WHO grade ≥3)(1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy)
- The incidence of severe oral mucositis (SOM) (WHO grade ≥3)(1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy)
- The time to onset of any-grade oral mucositis (OM)(1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy)
- The duration of any-grade oral mucositis (OM)(1 week before radiotherapy; weekly during radiotherapy(until 7 weeks); 1, 2, 3 months after the end of radiotherapy)
研究者
Xingchen Peng
Study director
West China Hospital