Effects of Prophylactic Swallowing Exercises on Dysphagia and Quality of Life in Patients With Head and Neck Cancer Receiving Radiotherapy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change in dysphagia severity at three months post radiotherapy
研究概览
简要总结
Head and neck cancer has a negative impact in swallowing function and quality of life. Rehabilitation has proven its usefulness after radiation therapy (RT), but some studies suggest that interventions should be initiated prior to RT sessions. This study aims to evaluate the effects of prophylactic rehabilitation on swallowing and quality of life. The study pretends to establish a preventive rehabilitative program with the target of reducing RT side effects and improve patients' quality of life.
详细描述
Head and neck cancer has a negative impact in swallowing function and quality of life. Although current diagnostic and therapeutic protocols try to preserve swallowing and speaking, acute or late dysphagia as well as a poor quality of life are frequent in these patients.
Some studies have reported an improvement in swallowing function after an exercise based intervention following radiation therapy (RT), regardless the need of concomitant chemotherapy (RT-QT). Other studies focus the interest in the use of prophylactic exercises to prevent or minimize post-swallowing dysfunction.
Patients receiving RT or RT-QT refer worsening of their quality of life, especially during the first days after treatment. One study suggests that rehabilitation prior to cancer treatment could potentially improve quality of life. However, this observation should be contrasted with a randomized study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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 advanced head and neck cancer receiving radiotherapy
排除标准
- •Candidates to surgical treatment
- •Previous head and neck cancer
- •Dysphagia due to causes other than cancer
- •Previous head or neck radiation therapy.
结局指标
主要结局
Change in dysphagia severity at three months post radiotherapy
时间窗: 2 weeks before beginning radiotherapy, and 3 months after completing radiotherapy
8-point Penetration Aspiration Scale: scores of 1-2 indicate normal swallowing, 3-5 reflect penetration, and \>6, aspiration
Change in quality of life at three months post radiotherapy
时间窗: 2 weeks before beginning radiotherapy and 3 months after completing radiotherapy
Head \& Neck Cancer 35 (HN35)
次要结局
- Change in dysphagia security signs at three months post radiotherapy(2 weeks before beginning radiotherapy and 3 months after completing radiotherapy)
- Change in lingual Force at three months post radiotherapy(2 weeks before beginning radiotherapy and 3 months after completing radiotherapy)
研究者
Esther Marco Navarro
PhD
Parc de Salut Mar