The Evaluation of Manual Therapy for the Prevention of Radiation-Induced Fibrosis in Patients With Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change from Baseline Functional oral intake scales at 3rd month
研究概览
简要总结
The subjects in this study are the patients with head and neck cancer after completion of the radiotherapy. Radiation-induced fibrosis is inevitable and there is no effective treatment to prevent it. Therefore, there are two parts in this study :
The first part is a pilot study. There will be 10 subjects included and manual therapy and rehabilitation will be arranged for 6 months. The manual therapy would be once a week at most, and the rehabilitation would be twice a week at most.
The second part is a randomized controlled study. 60 patients would be randomized divided into two groups. The group 1 is manual therapy(once a week at most) and rehabilitation(twice a week at most), and the group 2 is rehabilitation only(twice a week at most). Patients would be evaluated at baseline, 3rd, 6th, and 12th month. The evaluation is including the degree of superficial soft tissue fibrosis, numerical rating scale of pain, range of motion(neck), range of motion(shoulder), width of mouth opening, EORTC QLQ C30, EORTC QLQ H&N 35, and functional oral intake scale. Besides, swallowing video fluoroscopy would be done at baseline, 6th, and 12th month.
When the subject completes the evaluation in the 12th month, the study is ended.
Because the radiation-induced fibrosis is progressed with time, we will follow up the condition of subjects at the next year and the following third year.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 20 years
- •Head and neck cancer
- •After Completion of radiation therapy for 4 to 6 weeks
- •Be willing to accept manual therapy and long-term follow up
排除标准
- •Recurrence, metastatic cancer, or concurrent second cancer
- •With post-radiation dermatitis at neck or shoulder
- •Current pregnancy or lactation
- •Life expectancy of < 12 months.
结局指标
主要结局
Change from Baseline Functional oral intake scales at 3rd month
时间窗: baseline and 3rd month
in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
Change from Baseline range of motion, neck at the 3rd month
时间窗: baseline and 3rd month
including neck flexion, extension, right and left lateral flexion, and lateral rotation
次要结局
- range of motion, shoulder(measure the range of motion at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year)
- Change from Baseline range of motion, neck at the the 6th month(baseline and 6th month)
- Change from Baseline Functional oral intake scales at 2nd year(baseline and 2nd year)
- EORTC QLQ C30(at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year)
- EORTC H&N 35(at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year)
- Change from Baseline Functional oral intake scales at 12th month(baseline and 12th month)
- Numerical rating scale of pain(at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year)
- Change from Baseline range of motion, neck at the the 3rd year(baseline and 3rd year)
- Change from Baseline Functional oral intake scales at 6th month(baseline and 6th month)
- Width of mouth opening(at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year)
- Swallowing Video Fluoroscopy(at baseline, the 6th month, and the 12th month)
- Change from Baseline range of motion, neck at the the 12th month(baseline and 12th month)
- Change from Baseline range of motion, neck at the the 2nd year(baseline and 2nd year)
- Change from Baseline Functional oral intake scales at 3rd year(baseline and 3rd year)