A Prospective Study of Prophylactic Gastrostomy in Head and Neck Cancer Patients Undergoing Chemoradiotherapy in Medical Practice
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- treatment interruption due to toxicity
研究概览
简要总结
The purpose of the study is to determine whether prophylactic gastrostomy leads to less treatment interruption and provide better quality of life in head and neck cancer patients receiving chemoradiotherapy.
详细描述
Nutritional status is one of the essential factor to determine outcome of chemoradiotherapy in head and neck cancer patients. Almost all these patients develop mucositis during the treatment, which usually leads to treatment interruptions and affects the efficacy of the treatment. Prophylactic gastrostomy has been accepted for these patients with improvement of quality of life. However, there is no prospective study confirming superiority of such treatment.
The investigators enrolled head and neck cancer patients who had the plan of chemoradiotherapy. The patients will be informed about both treatment arms and will decide the arm that they preferred. The treatment interruptions, body weight and nutritional status will be assessed every 2 weeks during treatment period.
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
- •pathologically confirmed of head and neck cancer
- •plan to have chemoradiotherapy session
- •Performance status of 0-2
排除标准
- •contraindications for percutaneous gastrostomy, eg coagulopathy, obstructed tumor
- •Body mass index less than 16 kg/m2
结局指标
主要结局
treatment interruption due to toxicity
时间窗: during period of chemoradiatherapy, an expected average of 6 weeks
次要结局
- quality of life(during period of chemoradiation, an expected avearage of 6 weeks)
研究者
suthinee ithimakin
Assistant professor
Mahidol University