中药漱口液治疗头颈癌患者受照射口腔粘膜炎的疗效评价
评价中药漱口水治疗和预防头颈癌患者放射性口腔黏膜炎的疗效和安全性——一项初步试验
研究概览
详细说明
接受标准放疗 (RT) 和化放疗 (chemo-RT) 的头颈 (H&N) 癌症患者中,分别约有 60% 和 90% 会发展为口腔粘膜炎。 口腔粘膜炎 (OM) 是一种剂量限制性不良事件,也会导致情绪和营养问题。 临床上,通常在放疗第一周结束时(10 Gy 后)观察到,并在 14-21 天或治疗结束时达到损伤峰值。 完成 RT 后,愈合大约需要 2 到 3 周。
接受同步化疗、接受总剂量超过 5,000 Gy、改变分次放疗、口腔卫生状况差、早期粘膜炎未使用抗生素、有吸烟史、饮酒的 NPC 患者发生 OM 的风险尤其高酒精、有营养状况问题,如厌食、营养不良、缺乏维生素、因特殊饮食要求而限制食物、有血液病或非理想的血液状况、肿瘤定位和分期较晚、接受免疫治疗、有既往口干(口干症),在之前的治疗周期中有 OM 发作和低 BMI 等。
根据多国癌症支持治疗协会和国际口腔肿瘤学会 (MASCC/ISOO) 的 OM 管理指南等权衡指南,最近的系统评价和研究,主要有以下几个部分进行干预:(1)基本口腔护理,(2) 抗炎剂,(3) 光生物调节,(4) 冷冻疗法,(5) 抗菌剂、涂层剂、麻醉剂和镇痛剂,(6) 生长因子和细胞因子,以及 (7) 天然和其他. 我们可以从上述方案中总结出一些预防 H&N 癌症成人接受 RT 的 OM 的建议:多药组合口腔护理方案(提高良好口腔卫生意识)、专业牙科护理(局部癌症治疗之前或期间的理想选择)和来自牙源性来源的全身感染),苄达明漱口水(作为中等剂量 RT 的抗炎剂(
对于中医 (CM) 干预,许多研究都回顾了漱口水或内服草药汤剂对 OM 的疗效。 尽管观察到了一些积极的结果,但其中大部分是通过应用不同的评估工具和缺乏生活质量 (QOL) 或自我报告的症状评估来进行的。 此外,干预时间和随访期通常不足(在放疗结束时停止),因此他们无法根据 OM 的正常进展和使用 CM 的安全性来审查 CM 的长期疗效。 因此,我们希望这项试点研究能够在严格的方案中评估 CM 的有效性和安全性。
研究类型
注册 (预期的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习联系方式
- 姓名:KWOK YIN AU, Doctor of Medicine
- 电话号码:+852 28733100
- 邮箱:davidau@cuhk.edu.hk
学习地点
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Hong Kong、香港
- Hong Kong Institute of Integrative Medicine
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接触:
- KWOK YIN AU, PhD
- 电话号码:+852 28733100
- 邮箱:davidau@cuhk.edu.hk
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
纳入标准:患者
- 年龄≥18 岁,已知诊断为非转移性下咽癌、喉癌、唇和口腔癌、鼻咽癌、口咽癌、鼻窦和鼻腔癌以及唾液腺癌。
- 是第一次接受头部或面部、颈部或口腔区域原发性肿瘤的放疗。
- 最近在 14 天内开始 RT。
- 由 CMP 根据修改后的世界卫生组织 (WHO) 粘膜炎等级 ≤ 1 评估口腔粘膜炎的状况。
- Karnofsky Performance Status (KPS) ≥ 60(患者偶尔需要帮助,但能够满足大部分个人需求将达到 60 或以上)。
- 能够阅读或理解并签署同意书。
排除标准:患者
- 接受同步放化疗。
- 在招募时已知治疗口咽部细菌或真菌感染的药物。
- 患有其他已知疾病,例如严重且不受控制的糖尿病(过去半年有伤口延迟愈合症状)或甲状腺功能亢进症(过去半年有严重口腔干燥症状),已知结缔组织疾病或已知人类免疫缺陷病毒( HIV)感染等。
- 已知对 CMORF-I 成分或葡萄糖-6-磷酸脱氢酶 (G6PD) 患者有过敏史。
- 已知怀孕或哺乳。
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:干预组:中药漱口和标准护理
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其他名称:
• 医院将提供标准护理,包括生理盐水或医用漱口水、可选的止痛药和抗生素。
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安慰剂比较:对照组:安慰剂和标准治疗
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• 医院将提供标准护理,包括生理盐水或医用漱口水、可选的止痛药和抗生素。
安慰剂颗粒,说明书同CMORF-I。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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最严重修改后的 WHO 粘膜炎等级比例的比较
大体时间:干预后期间从基线到放疗结束后第 12 周
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干预后期间从基线到放疗结束后第 12 周
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
10cm 口腔疼痛视觉模拟量表 (VAS)
大体时间:干预期每周第3天、第7天(±1d)、干预后RT放疗结束后第4周末、第8周、第12周。
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它是口腔疼痛的量度。
通过在代表左侧“无痛”和右侧“最痛”之间的连续统一体的 10 厘米线上做一个手写标记来记录分数。
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干预期每周第3天、第7天(±1d)、干预后RT放疗结束后第4周末、第8周、第12周。
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口腔粘膜炎每日问卷(OMDQ)(修改后验证中文版)
大体时间:干预期每周第3天和第7天(±1d),干预后每周1次,干预后RT结束后第4周、第8周和第12周。
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它是对自我报告的生活质量的衡量。
它包含 10 个项目,对于 OMDQ 中的大多数问题,较高的分数表示症状严重程度恶化或对功能活动的干扰更多。
对于与整体健康有关的问题,得分越高表示整体健康状况越好。
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干预期每周第3天和第7天(±1d),干预后每周1次,干预后RT结束后第4周、第8周和第12周。
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欧洲癌症研究与治疗组织生活质量问卷(头颈)(EORTC QLQ-C30)(香港粤语版)
大体时间:干预期间每周第7天(±1天)、干预后期间放疗结束后第4周、第8周和第12周。
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它是头颈癌患者自我报告的生活质量的具体衡量标准。
它由 30 个问题组成,这些问题表明您在过去一周内遇到这些症状或问题的程度。
评分从 1“一点也不”到 4“非常”。
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干预期间每周第7天(±1天)、干预后期间放疗结束后第4周、第8周和第12周。
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欧洲癌症研究与治疗组织生活质量问卷(头颈)(EORTC QLQ-H&N35)(香港粤语版)
大体时间:干预期间每周第7天(±1天)、干预后期间放疗结束后第4周、第8周和第12周。
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它是头颈癌患者自我报告的生活质量的具体衡量标准。
它包含 35 个问题,表明您在过去一周内遇到这些症状或问题的程度。
评分从 1“一点也不”到 4“非常”。
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干预期间每周第7天(±1天)、干预后期间放疗结束后第4周、第8周和第12周。
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体重指数 (BMI)
大体时间:干预后期间从基线到放疗结束后第 12 周
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它是一种基于身高和体重的体脂量测量方法,适用于成年男性和女性。
它可以在一定程度上评估和监控 OM 的风险。
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干预后期间从基线到放疗结束后第 12 周
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每天使用镇痛药和抗生素的次数
大体时间:干预后期间从基线到放疗结束后第 12 周
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它可以评估和监测 OM 的状况。
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干预后期间从基线到放疗结束后第 12 周
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合作者和调查者
调查人员
- 首席研究员:KWOK YIN AU, Doctor of Medicine、Hong Kong Institute of Integrative Medicine
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