Preventive Randomized Study Regarding Physical Activity Intervention for Patients Receiving Radiotherapy for Head and Neck Cancer: the Effect of Preventive Intervention for Physical Activity, Function and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Objectively measured physical activity
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 physical activity protocol before and during radiotherapy) or a control group not performing a specified physical exercise protocol. All patients will be in contact with with a speech language pathologist or a physical therapist weekly during radiotherapy. The study is expected to improve physical function and quality of life during and after oncologic treatment
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 radiohterapy (+/- chemotherapy) with curative intent
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 perform part of 6-minute walking test
- •Inability to independently fill out questionnaires in Swedish
- •Previous neurologic or neuromuscular disease
研究组 & 干预措施
Physical exercise intervention
The physical activity intervention is based on national guidelines of physical activity in cancer rehabilitation. A physiotherapist together with each patient will develop individual adaptations to the exercise protocol, with suggestions on which type of exercise the participant is able to perform depending on their daily condition. Suggestions on physical activity for good, bad and in-between-days will be listed in collaboration with the participant, and the participant will report number of minutes/day in each of the 3 physical activity levels stated.
干预措施: Preventive physical exercise (Behavioral)
Control
The control group will receive general advice on the importance of physical activity during oncologic treatment, according to local clinical standard.
结局指标
主要结局
Objectively measured physical activity
时间窗: Up to 12 months
Measured with an accelerometer. Measures time spent in different activities i minutes/day.
Subjectively measured physical activity (IPAQ)
时间窗: Up to 12 months
Measured with the International Physical Activity Questionnaire
Subjectively measured physical activity - Saltin-Grimby
时间窗: Up to 12 months
Measured with the Saltin-Grimby physical activity level scale and the International Physical Activity Questionnaire.
次要结局
- Health related quality of life (HRQL) using the EORTC QLQ H&N35(Up to 5 years post radiotherapy)
- Maximal Interincisal opening (MIO)(Up to 5 years post radiotherapy)
- Body composition(Up to 12 months post radiotherapy)
- Grip strength(Up to 12 months post radiotherapy)
- Health related quality of life (HRQL) using the EORTC QLQ-C30(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)
- 6-minute walking test(Up to 12 months post radiotherapy)
研究者
Lisa Tuomi
Principal Investigator
Sahlgrenska University Hospital