Radiation-Induced Fibrosis in Patients With Head and Neck Cancer
Conditions
Keywords
Head and neck cancer, Post-radiation fibrosis, Manual therapy, Rehabilitation
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.
Interventions
PROCEDUREmanual therapy
1. release and stretch the muscles and fascia around shoulder girdle、upper arm and forearm; 2. massage the masseter muscle and temporalis muscle; 3. mobilization of the temporomandibular joint, the thoracic and cervical spine, shoulder, and elbow.
PROCEDURESpeech therapy
include the stretching of the neck, facial and oral movement training, and swallowing training
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
: 1. Age \> 20 years 2. Head and neck cancer 3. After Completion of radiation therapy for 4 to 6 weeks 4. Be willing to accept manual therapy and long-term follow up
Exclusion criteria
: 1. Recurrence, metastatic cancer, or concurrent second cancer 2. With post-radiation dermatitis at neck or shoulder 3. Current pregnancy or lactation 4. Life expectancy of \< 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 6th month | baseline and 6th month | including neck flexion, extension, right and left lateral flexion, and lateral rotation |
| 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 |
| 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 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. |
| 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 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. |
| 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. |
| 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 |
| 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 |
Countries
Taiwan
Contacts
Primary ContactTsung-Hsien Yang, MD
Outcome results
None listed