Randomized, Controlled Clinical Study of Using Massage of Maxillofacial and Oral Cavity to Prevent Oral Mucositis in Patients With Nasopharyngeal Carcinoma Undergoing Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Incidence of severe radioactive oral mucositis
研究概览
简要总结
A total of 160 cases of nasopharyngeal carcinoma patients who met the inclusion criteria were randomly assigned to two groups. The experimental group was given massage of maxillofacial and oral cavity plus routine oral care and functional exercise. The control group was given routine oral care and functional exercise. Analyze the difference of incidence of severe acute radioactive oral mucositis in these two groups.
详细描述
160 nasopharyngeal carcinoma patients were enrolled and randomly assigned to two groups in a 1:1 ratio. The experimental group was given massage of maxillofacial and oral cavity plus routine oral care and functional exercise, the control group was only given routine oral care and functional exercise. Assess the condition of oral mucosa, according to the grading standard of RTOG acute radiation injury, everyday during radiotherapy. After radiotherapy, follow up the condition of oral mucosa one time per month for a total three times. Then analyze the incidence difference between two groups.
massage method：The duration of the massage lasts from the first day of radiotherapy to three months after the end of radiotherapy，5 times a day（After getting up, before breakfast, lunch, dinner and going to bed). massage of maxillofacial includes the left and right cheeks, the upper jaw, the lower jaw, and around the mouth. Oral Massage includes the tongue, hard palate, the gums, and the bucca. Each part lasts 1-2min，repeating 3 cycles each time. Patients who could finished at least 75% are included in the statistical analysis.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed by pathology with nasopharyngeal carcinoma;
- •ECOG PS: 0-2;
- •Gender is not limited, Age between 18 years old and 70 years old.
- •Clear consciousness, no mental illness or cognition impairment;
- •The expected survival time is more than 12 months;
排除标准
- •Patients with other severe diseases affecting the quality of life or the treatment process;
- •Unwilling to actively cooperate with investigators;
- •Patients with previous oral diseases;
- •Patients who have received head and neck surgery and radiotherapy;
- •A history of psychotropic substance abuse or a mental disorder;
- •Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment;
- •Women who are pregnant or in lactation;
- •Other situations that may affect the results of the clinical study.
研究组 & 干预措施
Control arm
routine oral care and functional exercise.
Massage arm
Massage of Maxillofacial and oral cavity plus routine oral care and functional exercise
干预措施: Massage of Maxillofacial and Oral Cavity (Other)
结局指标
主要结局
Incidence of severe radioactive oral mucositis
时间窗: 3 months
the status of oral mucosa was evaluated daily during radiotherapy. According to the grading standard of RTOG acute radiation injury, statistical analysis was made on whether there was a difference and statistical significance in the incidence rate of oral mucositis with radiation above grade 3 between the two groups.
次要结局
- the time at which the radioactive oral mucosa occurred; Difficulty in opening your mouth.(3 months)
研究者
Jianguo Sun
Professor
Xinqiao Hospital of Chongqing