A Randomised Phase III Trial of Radiotherapy With Humidification in Head And Neck Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Intensity of mucositis as a function of time for CTCAE grade > 1 mucositis (e.g. grade 2 or higher) measured as the area under the time curve (AUC) of the plot expressing grade of acute reactions vs weeks for observed CTCAE mucosal reactions > 1.
研究概览
简要总结
This is a two arm randomised phase III trial which will evaluate prospectively the benefits of humidification in patients receiving radiotherapy / chemoradiation for head and neck cancer. The intent of humidification is to moisturise the mucosa. The rationale for the use of humidification with radiotherapy can be considered an extension of the general principle of moist wound care in wound management.
详细描述
This phase III trial will address four hypotheses. The primary hypothesis is:
Humidification will modulate the natural history of mucositis resulting in a clinically significant reduction in the intensity of severe acute mucositis as a function of time for CTCAE grade > 1 mucositis (e.g. grade 2 or higher), measured as the area under the time curve (AUC) of the plot expressing grade of acute reactions vs weeks for observed CTCAE mucosal reactions > 1
The additional hypotheses are:
- Humidification will palliate the acute symptoms of mucositis and xerostomia
- Humidification is cost effective through a reduction in hospital bed occupancy
- Humidification will improve the functional outcome, particularly swallowing function, of patients with head and neck cancer treated with radiotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patients who meet the following criteria will be eligible:
- •Pathologically confirmed diagnosis of cancer involving the Nasopharynx, Oropharynx, Oral Cavity, Larynx, or Hypopharynx
- •Regional nodal irradiation included in PTV1 (as a minimum ipsilateral levels II-III)
- •Prescribed dose of radiotherapy is at least 60 Gy
- •Receiving definitive or post-operative adjuvant Radiotherapy
- •Receiving Radiotherapy as sole modality or Chemoradiation
- •Patient > 18 years old
- •Available for follow-up for up to 2 years
- •Life expectancy greater than 6 months
- •Written informed consent
- •Participation of patients on other clinical trial protocols permitted
排除标准
- •Patients who meet the following criteria will be excluded:
- •Presence of tracheostomy or stoma
- •Diagnosis of T1 / T2 glottic carcinoma
- •Undergoing CPAP therapy -Treatment with Amifostine or Palifermin (keratinocyte growth factor) during radiotherapy
- •History of previous radiotherapy to the head and neck region, excluding superficial radiotherapy to cutaneous squamous cell carcinoma or basal cell carcinoma
- •High risk for poor compliance with radiotherapy, humidification, or follow-up as assessed by the investigator
研究组 & 干预措施
Standard of Care
Standard of Care
干预措施: Standard of Care (Other)
Humidification
Humidification
干预措施: Humidification (Device)
结局指标
主要结局
Intensity of mucositis as a function of time for CTCAE grade > 1 mucositis (e.g. grade 2 or higher) measured as the area under the time curve (AUC) of the plot expressing grade of acute reactions vs weeks for observed CTCAE mucosal reactions > 1.
时间窗: week 12
次要结局
未报告次要终点