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
- Interventions
- Procedure: Speech therapyProcedure: manual therapy
- Registration Number
- NCT04850170
- Lead Sponsor
- Chang Gung Memorial Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Speech therapy The control group will be arranged rehabilitation. Experimental group manual therapy 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. Experimental group Speech therapy 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.
- Primary Outcome Measures
Name Time Method Change from Baseline range of motion, neck at the 3rd month baseline and 3rd month including neck flexion, extension, right and left lateral flexion, and lateral rotation
Change from Baseline Functional oral intake scales at 3rd month 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.
- Secondary Outcome Measures
Name Time Method 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 to measure the degree of bilateral shoulder, including flexion, extension, abduction, adduction, external rotation, and internal rotation
Change from Baseline range of motion, neck at the the 6th month baseline and 6th month including neck flexion, extension, right and left lateral flexion, and lateral rotation
Change from Baseline Functional oral intake scales at 2nd year baseline and 2nd year in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
EORTC QLQ C30 at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year the most widely used questionnaire for cancer patients; explore aspects of quality of life assessment, evaluation and interpretation.
EORTC H&N 35 at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year questionnaire for head and neck cancer patients.
Change from Baseline Functional oral intake scales at 12th month baseline and 12th 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 the 3rd year baseline and 3rd year including neck flexion, extension, right and left lateral flexion, and lateral rotation
Change from Baseline Functional oral intake scales at 6th month baseline and 6th month in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
Width of mouth opening at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year measure the maximum interincisal opening and range of the jaw and mouth
Numerical rating scale of pain at baseline, the 3rd month, the 6th month, the 12th month, the second year, and the third year evaluate the pain degree(0\~10); higher scores mean a worse outcome
Swallowing Video Fluoroscopy at baseline, the 6th month, and the 12th month 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.
Change from Baseline range of motion, neck at the the 12th month baseline and 12th month including neck flexion, extension, right and left lateral flexion, and lateral rotation
Change from Baseline range of motion, neck at the the 2nd year baseline and 2nd year including neck flexion, extension, right and left lateral flexion, and lateral rotation
Change from Baseline Functional oral intake scales at 3rd year baseline and 3rd year in this scales, the maximum values is grade seven, the minimum values is grade one. The higher scores mean a better outcome.
Trial Locations
- Locations (1)
New Taipei Municipal Tucheng Hospital
🇨🇳New Taipei City, Taiwan