Evaluating the Effectiveness of a Novel Skin Barrier Protectant in the Prevention and Management of Acute Radiodermatitis in Patients With Head and Neck Cancer: a Prospective Cohort Study With Historical Controls
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Radiodermatitis grading
研究概览
简要总结
Acute radiodermatitis (ARD) is a distressing and painful skin reaction that occurs in 95% of the patients undergoing radiotherapy (RT). To date, there is still no general approved guideline for the prevention and management of acute radiodermatitis. The 3M™ Cavilon™ Advanced Skin Protectant is a novel skin barrier protectant that acts as a physical barrier against abrasion, moisture, and irritants. Moreover, it enables an environment for wound healing. The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the prevention and management of ARD in patients with head and neck cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of head and neck squamous cell carcinomas (HNSCC) starting in the lip, salivary gland, oral cavity (mouth), nasal cavity (inside the nose), paranasal sinuses, pharynx, or larynx.
- •Scheduled for bilateral neck radiotherapy (>60 Gy) with or without concomitant chemotherapy either as primary or as post-operative treatment to the head and neck region
- •Age ≥ 18 years
- •Able to comply to the study protocol
- •Able to sign written informed consent
- •Signed written informed consent
排除标准
- •Previous irradiation to the head and/or neck region
- •Metastatic disease
- •Patients with pre-existing skin rash, ulceration or open wound in the treatment area
- •Patients with known allergic and other systemic skin diseases even when not directly affecting irradiated fields
- •Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator
- •Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator
- •Patients using high doses of non-steroidal anti-inflammatory drugs
- •Patients allergic to the ingredients of the 3M™ Cavilon™ Advanced Skin Protectant
结局指标
主要结局
Radiodermatitis grading
时间窗: Day 47
National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.03
Radiodermatitis severity
时间窗: Day 47
Radiation-Induced Skin Reaction Assessment Scale (0- 36, with a higher score correlating with a more severe skin reaction)
次要结局
- General satisfaction(day 47)
- Quality of life measurement(day 47)