Physiotherapy Versus no Physiotherapy to Patients Suffering From Head and Neck Cancer Undergoing Radiotherapy Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- The amplitude of mouth opening
研究概览
简要总结
The purpose of this study is to investigate whether the extent of late sequelae symptoms(reduced mouth opening, lymphoedema, decreased range of motion in the neck and shoulder region, speech and swallow disorders and reduced facial expression) due to radiotherapy treatment for head and neck cancer can be reduced by an individually adjusted physiotherapy effort applied immediately after the onset of and during radiotherapy treatment.
详细描述
In Denmark there are about 1000 new cases of head and neck cancer every year. The number is increasing. The treatment for head and neck cancer is either surgery or radiotherapy treatment or a combination of these modalities. Radiotherapy treatment for head and neck cancer often causes severe late term side effects.
Radiotherapy induced damage of the skin, lymphatic system, cartilage and bone often leads to symptoms such as trismus, lymphoedema, decreased range of motion of the mouth, neck and tongue, difficulty in using the mimic muscles, difficulty in swallowing and pain. The severity of late side effects due to radiotherapy treatment for head and neck cancer often leaves the patients with a poor quality of life rating.
Effects of physiotherapy interventions are scarcely investigated. Only few studies describe the effect of physiotherapy treatment. The studies are difficult to compare because of insufficiently described physiotherapy intervention, or variation of onset and extent of physiotherapy intervention plus variation in study populations. No studies have described the long term effects of physiotherapy intervention. There is no national or international consensus for the physiotherapy treatment for patients undergoing treatment for head and neck cancer.
Primary hypothesis:
Decreased mouth opening in patients suffering from c.cavi oris and c.oropharynges undergoing radiotherapy treatment, can be reduced by an early physiotherapy effort compared with the present circumstances.
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 (Investigator)
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 the clinical diagnosis of cancer cavi oris or cancer oropharynges undergoing radiotherapy treatment
- •Age > 18 years
- •Informed consent
排除标准
- •Patients who have had bone reconstruction surgery or grafting or where motor nerve damage has occurred during surgery, inflicting the function of the neck or shoulder
- •Patients suffering from a known musculoskeletal disease with symptoms that may influence/disturb the picture of symptoms induced by radiotherapy to the tempora-mandibular joint, the cervical spine, shoulders (e.g R.A, fibromyalgia, arthritis,neurological disease, industrial injury)
- •Patient with psychiatric diagnosis, who are unable to cooperate (including dementia)
- •Patients whose general condition makes it impossible to attend the study (weak and feeble)
- •Patients who do not master the Danish language in a degree, that they can read and understand written and verbal information
- •The lack of informed consent
结局指标
主要结局
The amplitude of mouth opening
时间窗: Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment
Maximum vertical dimension measured in millimetre using TheraBite "Range of Motion Scale"
次要结局
- Tongue movement(Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment)
- Active range of motion of the cervical spine(Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment)
- Lymphoedema(Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment)
- Tightness of tissue(Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment)
- Self estimated quality of life rating. EORTC QLQ-C30 and QLQ-H&N35(Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment)
- Pain(Baseline: day 1 or 2 of radiotherapy treatment, 5 months after completing radiotherapy treatment and 12 months after completing radiotherapy treatment)