Randomized Controlled Multicenter Trial to Evaluate the Effects of Ethyl-2-cyanoacrylate on Pain Intensity and Quality of Life in Head and Neck Cancer Patients Suffering From Cetuximab-induced Rhagades During Radioimmunotherapy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale (VAS)
研究概览
简要总结
The SUPPORT trial is an open-label, prospective, randomized, national multicenter intervention study to evaluate the effectiveness of ethyl-2-cyanoacrylate versus the standard treatment of each institution on the pain intensity and QoL in patients with locally advanced head and neck cancer suffering from painful cetuximab-induced rhagades during radioimmunotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally advanced squamous cell carcinoma of the head and neck and participation in the HICARE-phase-IV-trial
- •Cetuximab-induced painful rhagades, i.e. SUPO Score 2-3 (see Figure 2)
- •Compliance to the photo documentation
- •Ability of subject to understand character and individual consequences of the clinical trial
- •Written informed consent
排除标准
- •Cetuximab-induced rhagades without any pain, i.e. SUPO Score 1
- •Cetuximab-induced rhagades, SUPO Score 4, i.e. superinfection of the rhagades
- •Patients not being enrolled in the HICARE trial
- •Substance misuse, psychoactive substance abuse or psychological/social conditions leading to a decreased patients' compliance with possible bad influence to the results of the study
- •Known allergic reaction to ethyl-2-cyanoacrylate (ECA)
研究组 & 干预措施
ECA: Ethyl-2-cyanoacrate
Application of ethyl-2-cyanoacrylate (ECA) for painful cetuximab-induced rhagades
干预措施: ECA (Device)
Standard treatment of the institution
Standard treatment of the institution to treat painful cetuximab-induced rhagades
干预措施: Standard topical treatment of the institution, e.g. Lotio (Other)
结局指标
主要结局
pain intensity 24 hours after application of ECA or the standard treatment quantified by the visual analogue scale (VAS)
时间窗: 24 hours after application
pain intensity quantified by the visual analogue scale (VAS)
次要结局
- Evaluation of QoL(5 to 7 days after application of treatment)