Randomised Pilot Study of Therabite® Versus Wooden Spatula in the Amelioration of Trismus in Head and Neck Cancer Patients. (Trismus Trial)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 10
- 主要终点
- Change in Jaw measurement
研究概览
简要总结
The trial will compare exercises using Therabite® versus wooden spatulas to prevent or relieve trismus in patients with stage 3 and 4 oral/oropharyngeal cancer.
详细描述
Trismus is defined as a tightening of jaw opening. The negative impact of Trismus on the quality of life of head and neck cancer patients is well established. It affects eating, drinking, speaking and social function and is often as debilitating as any disfigurement resulting from treatment.
The use of jaw exercises using a Therabite appliance following treatment has been shown to reduce the level of Trismus in small studies. Many UK centres, however, use stacked wooden spatulas inserted between the incisors as a means of passive exercise. There is anecdotal evidence that suggests the use of exercises prior to treatment may help reduce the severity of the Trismus experienced by the patient.
This study will enrol 112 head and neck cancer patients allocated by chance to use either the Therabite or wooden spatula and patients will be asked to perform mouth exercises on a daily basis for 6 months.
There is a need to evaluate both the clinical effectiveness and cost-effectiveness of Therabite as opposed to wooden spatulas to determine whether they should be adopted as standard care in head and neck cancer patients.
In this pilot trial, the investigators will measure benefits of Therabite to patients, as compared to usual care with wooden spatulas. Mouth opening will be the key outcome for the 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
- 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
- •Provision of signed, written informed consent
- •Aged 18 years and older
- •Able to read and write English sufficiently to be able to complete questionnaires
- •Stage 3/4 oral and oropharyngeal cancer patients undergoing:
- •Primary chemoradiotherapy or Surgical free flap plus post operative radiotherapy or post operative chemoradiotherapy
- •All patients will receive 60-70 Gy in 30-35 fractions over 6 to 7 weeks to the region of the pterygoid muscles.
- •All patients will have at least some trismus as indicated by subjective tightening in the jaw.
排除标准
- •<12mm mouth opening (cannot use Therabite)
- •Anatomically unable to use Therabite for example patients who may only be partially dentate and to use the Therabite would place extreme stress on the existing teeth
- •Cognitive impairment as judged by the clinicians
- •International patients treated who will not have routine UK follow up.
- •Previous surgery or RT to the head and neck prior to this diagnosis
- •Any patient who has no subjective tightening of the jaw.
结局指标
主要结局
Change in Jaw measurement
时间窗: Baseline, 3 months and 6 months at hopsital
Willis bite calliper will be used to measure the jaw opening at baseline, 3 and 6 months
次要结局
- Adherence to intervention(up to 6 months)
- Health economic analysis(Baseline, 3 and 6 months)
- Quality of Life(Baseline, 3 and 6 months)
研究者
Brynn Chappell
Clinical Trials Project Manager
The Christie NHS Foundation Trust