Implementation of an Intraoral Stent in Radiotherapy of Tongue Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Reduction in mean dose to the hard palate
研究概览
简要总结
Radiotherapy of tongue cancer is associated with acute and late morbidity. Use of an intraoral stent will provide a larger distance between the tongue and palate and can reduce side-effects. The aim of the present study is to confirm that an intraoral stent will give lower dose to the palate throughout the treatment period.
详细描述
Radiotherapy of tongue cancer is associated with acute and late morbidity. Use of an intraoral stent will provide a larger distance between the tongue and palate and can reduce side-effects. The main objective of the present study is to confirm that the use of an intraoral stent will result in lower dose to the palate throughout the treatment period. A secondary objective is to measure the reduction in acute mucositis in the palate.
The intraoral stent used in the present study is available in two sizes, 10 and 20mm thickness. The intervention group and control group will consist of approximately five patients each. Target coverage will be measured by the minimum dose covering 98% of the clinical target volume (D98CTV). Dose to the organs at risk (hard and soft palate) will be measured by the mean dose. Data will be collected from the planning computed tomography (CT) and daily cone-beam CT (CBCT). Acute mucositis will be scored by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Patients with tongue cancer
- •Curatively intended radiotherapy requiring a total dose of 50-70 Gy
- •Age >18 years
- •Performance status, Eastern Cooperative Oncology Group (ECOG) 0-2
排除标准
- 未提供
研究组 & 干预措施
Control group
N=7
干预措施: No intraoral stent (Other)
Intervention group
N=6
干预措施: Intraoral stent (Device)
结局指标
主要结局
Reduction in mean dose to the hard palate
时间窗: At the end of radiotherapy (5-6 weeks)
Mann-Whitney U test.
次要结局
- Reduction in mean dose to the soft palate(At the end of radiotherapy (5-6 weeks))
- Reduction in acute mucositis in the soft palate(At the end of radiotherapy (5-6 weeks))
- Reduction in acute mucositis in the hard palate(At the end of radiotherapy (5-6 weeks))
研究者
Einar Dale
Senior Consultant
Oslo University Hospital