Radioprotective Effect of Chinese Herbal Medicine on Ionizing Radiation-Induced Oral Mucositis
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 主要终点
- Degree of oral mucositis
研究概览
简要总结
This protocol describes a randomized, double-arm, parallel-group, open-label controlled study that aims to evaluate the efficacy of Chinese herbal medicine on head and neck cancer patients with oral mucositis toxicities and quality of life during radiotherapy.
详细描述
200 head and neck cancer patients who were scheduled for radiotherapy are randomly assigned at a 1:1 ratio to two arms: control group and those treated with Zi-Yin-Liang-Ge-San containing Rx. Scutellariae, Rx. Glycyrrhizae, Hb. Dendrobii, Rx. Ophiopogonis, and Hb. Menthae Haplocalycis from day 1 of radiotherapy. The study lasted at least 6 weeks and the clinical benefit was determined by onset, gradation of mucositis (Common Terminology Criteria for Adverse Events v5.0), oral pain (visual analysis scale) for each week during RT. Nutritional status, EORTC Quality of Life Core Questionnaire (QLQ-C30) and head and neck module (QLQ-H&N35), Body Constitution Questionnaire (BCQ), and electrical body conductivity were evaluated before and after radiotherapy. Patient-Reported Outcomes version of Common Terminology Criteria for Adverse Events (PRO-CTCAE), serious adverse events, blood and biochemical analysis will be recorded to evaluate the safety.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven stage II-IV squamous HNC
- •Indication for radiotherapy or radio-chemotherapy
- •No history of antitumor therapies
- •No history of oral ulcer and salivary gland diseases
- •Normal vital signs (body temperature: 36 to 37.5∘C, heart rate: 60 to 100 beats per minute, respiratory rate: <20 per minute, and mean arterial pressure: 70 to 100mmHg), and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
排除标准
- •Terminal cancer for which aggressive treatments were not suitable
- •Impaired renal or hepatic function at initial diagnosis (including chronic kidney disease stages III, IV, and V and Aspartate transaminase (AST), Alanine aminotransferase (ALT) ≥5 × the upper normal limit)
- •Uncontrolled psychiatric problems or altered mental status
- •Had received medications for other clinical trials
研究组 & 干预措施
Chinese herbal medicine treatment
干预措施: Zi-Yin-Liang-Ge-San (Drug)
结局指标
主要结局
Degree of oral mucositis
时间窗: During the radiotherapy course, up to 6 weeks
The degree was graded by the NHI Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Mucositis pain
时间窗: During the radiotherapy course, up to 6 weeks
100-mm-visual analog scale (VAS, 0-100)
次要结局
- Body mass index (BMI)(During the radiotherapy course, up to 6 weeks)
- Health related-QoL (1)(Baseline, 4th week, and 6th week of radiotherapy completion)
- Health related-QoL (2)(Baseline, 4th week, and 6th week of radiotherapy completion)