Preventive Randomized Study Regarding Jaw- and Swallowing Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer: the Effect of Preventive Intervention for Trismus, Swallowing Function and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Maximal Interincisal opening (MIO)
研究概览
简要总结
The study includes patients with tumors of the oropharynx, larynx and hypopharynx scheduled to receive radiotherapy with curative intent (+/- chemotherapy). The patients will be randomized into either an intervention group (performing a preventive jaw- and swallowing exercise protocol before and during radiotherapy) or a control group no performing a exercise protocol. All patients will be encouraged to eat or drink for as long as possible during the therapy. All patients will meet with a speech-language therapist weekly during radiotherapy.
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 (Participant)
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
- •Head and neck cancer (tumors of the oropharynx, pharynx, hypopharynx and larynx)
- •Receiving radiohterpay (+/- chemotherapy) with curative intent
- •No previous trismus or dysphagia
排除标准
- •Surgery due to head and neck cancer
- •Previous treatment for head and neck cancer
- •Tracheostomized patients
- •Inability to perform exercise intervention
- •Inability to independently fill out questionnaires in Swedish
- •Previous neurologic or neuromuscular disease
结局指标
主要结局
Maximal Interincisal opening (MIO)
时间窗: 1 month post radiotherapy
Jaw opening measured in millimeters. A MIO \<36 mm is considered as trismus. i.e. limited jaw-opening.
Swallowing ability
时间窗: 1 month after radiotherapy
Swallowing ability measured with Functional Endoscopic Examination of Swallowing (FEES)
次要结局
- Maximal Interincisal opening (MIO)(Up to 5 years post radiotherapy)
- Swallowing ability(Up to 5 years post radiotherapy)
- Dysphagia related symtoms(Up to 5 years post radiotherapy)
- Trismus and jaw related symptoms(Up to 5 years post radiotherapy)
- Health related quality of life (HRQL)(Up to 5 years post radiotherapy)
研究者
Lisa Tuomi
Principal Investigator
Vastra Gotaland Region