The Evaluation of Manual Therapy for the Prevention of Radiation-Induced Fibrosis in Patients With Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
The Evaluation of Manual Therapy for the Prevention of Radiation-Induced Fibrosis in Patients With Head and Neck Cancer

Conditions
-----------------
Radiation-Induced Fibrosis in Patients With Head and Neck Cancer

Intervention / Treatment
-----------------
* Procedure: manual therapy
* Procedure: Speech therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : 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 Exclusion Criteria : Recurrence, metastatic cancer, or concurrent second cancer With post-radiation dermatitis at neck or shoulder Current pregnancy or lactation Life expectancy of < 12 months.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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 now. 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>The first ten subjects will be enrolled in a pilot study. The following sixty subjects will be separated randomly to experimental group and control group. The first ten subjects and the experimental group will be arranged manual therapy and rehabilitation for six months. | Procedure: manual therapy<br>* release and stretch the muscles and fascia around shoulder girdle、upper arm and forearm; massage the masseter muscle and temporalis muscle; mobilization of the temporomandibular joint, the thoracic and cervical spine, shoulder, and elbow.<br>Procedure: Speech therapy<br>* include the stretching of the neck, facial and oral movement training, and swallowing training<br>|
| Active Comparator: Control group<br>The control group will be arranged rehabilitation. | Procedure: Speech therapy<br>* include the stretching of the neck, facial and oral movement training, and swallowing training<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline range of motion, neck at the 3rd month | including neck flexion, extension, right and left lateral flexion, and lateral rotation | baseline and 3rd month | 
| Change from Baseline Functional oral intake scales at 3rd month | in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome. | baseline and 3rd month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| range of motion, shoulder | to measure the degree of bilateral shoulder, including flexion, extension, abduction, adduction, external rotation, and internal rotation | measure the range of motion at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year | 
| Width of mouth opening | measure the maximum interincisal opening and range of the jaw and mouth | at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year | 
| EORTC QLQ C30 | the most widely used questionnaire for cancer patients; explore aspects of quality of life assessment, evaluation and interpretation. | at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year | 
| EORTC H&N 35 | questionnaire for head and neck cancer patients. | at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year | 
| Numerical rating scale of pain | evaluate the pain degree(0 10); higher scores mean a worse outcome | at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year | 
| Swallowing Video Fluoroscopy | Observe that the patient swallows items with different thicknesses and textures via using a special real-time form of x-ray. This examination allows us to test the ability to swallow safely and effectively. | at baseline, the 6th month, and the 12th month | 
| Change from Baseline range of motion, neck at the the 6th month | including neck flexion, extension, right and left lateral flexion, and lateral rotation | baseline and 6th month | 
| Change from Baseline range of motion, neck at the the 12th month | including neck flexion, extension, right and left lateral flexion, and lateral rotation | baseline and 12th month | 
| Change from Baseline range of motion, neck at the the 2nd year | including neck flexion, extension, right and left lateral flexion, and lateral rotation | baseline and 2nd year | 
| Change from Baseline range of motion, neck at the the 3rd year | including neck flexion, extension, right and left lateral flexion, and lateral rotation | baseline and 3rd year | 
| Change from Baseline Functional oral intake scales at 6th month | in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome. | baseline and 6th month | 
| Change from Baseline Functional oral intake scales at 12th month | in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome. | baseline and 12th month | 
| Change from Baseline Functional oral intake scales at 2nd year | in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome. | baseline and 2nd year | 
| Change from Baseline Functional oral intake scales at 3rd year | in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome. | baseline and 3rd year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Head and neck cancer, Post-radiation fibrosis, Manual therapy, Rehabilitation