A Randomized,Controlled Clinical Trial on the Efficacy and Safety of Chining Decoction in the Treatment of Radiation Stomatitis.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Grading standard of RTOG in acute radiation injury of oral mucosal
研究概览
简要总结
This study evaluates the efficiency and safety of ChiNing decoction to head and neck cancer patients with radioactive stomatitis. Half of participants will receive ChiNing decoction, while others will receive recombinant human epidermal growth factor (rhEGF) spray.
详细描述
This study uses randomized, controlled clinical research methods, through the observation of the treatment group (ChiNing decoction orally) and control group (recombinant human epidermal growth factor rhEGF spray on oral mucosal surface ) at different time points before and after radiotherapy, to evaluate the radiotherapy of acute radiation oral mucosa reaction (RTOG grade), quality of life score (EORTCQLQ-H&N35 scale), oral pain (VAS score) and patient body weight changes of the two groups. At the same time，this study takes cast-off cells of oral mucosal to observe the microscopic characteristics of oral mucosa, and uses the ELISA method to detect IL-6 and TNF- alpha content in the saliva before and after radiotherapy.
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
- None
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
- 是
入选标准
- •Head and neck cancer patients with pathology and / or cytologic diagnosis;
- •Age 18~75 years old;
- •The expected life is more than 3 months;
- •The Karnofsky score (Karnofsky) ≥70 points;
- •The first course of radiotherapy in patients;
- •Patients had not received any anti tumour therapies for example of operation, radiotherapy,chemotherapy, biological treatment or isotope therapy system;
- •Patients volunteered to participate in this test and signed the informed consent, understand the purpose and test steps of the test, good compliance, comply with the relevant requirements of this test scheme;
- •No history of oral ulcer and salivary gland diseases
排除标准
- •That do not meet the above the inclusion criteria;
- •Advanced critical cases, the expected survival is less than 3 months;
- •The patients had serious complications, such as cachexia, hepatic encephalopathy, gastrointestinal bleeding and coagulation functionobstruction, su ch as abnormal;
- •The submandibular gland pathological changes;
- •During radiotherapy taking other drugs in patients with treatment of stomatitis;
- •The patients with serious heart, brain, liver, kidney function
研究组 & 干预措施
ChiNing decoction
60ml ChiNing decoction by mouth，three times a day for 46 days.
干预措施: ChiNing decoction (Drug)
结局指标
主要结局
Grading standard of RTOG in acute radiation injury of oral mucosal
时间窗: 8 days
Score before the radiotherapy and every 1 week after the begining of the radiotherapy and after the end of radiotherapy
次要结局
- The visual analogue scale of oral pain(8 days)
- EORTCQLQ-H&N35(8 days)
- patient body weight changes(8 days)
- Safety index(2 days)