Effects of Exercise Therapy Adjuvant Device on Head and Neck Cancer Patients in the Treatment of Cancer Therapy Induced Trismus

Study Overview
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Brief Summary
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Trismus is traditionally considered being a late effect of cancer therapy with functional deficits becoming clear in the first year after completing radiation therapy. These deficits can rapidly progress to a state of functional impairment. The most common treatment for trismus is physical therapy comprising an active range of motion (ROM) exercises, hold and relax techniques. Once trismus has developed, it may be hard to reverse. Thus, prevention with a program of self-care is important for managing this side effect. This study want to test the effect with adjunctive devices plus exercise to prevent trismus.

Official Title
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A Randomized Feasibility Trial to Test Exercise Therapy Plus Jaw Device to Prevent Trismus in Patients With Head and Neck Cancer Receiving Radiation-Based Therapy

Conditions
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Maximum Interincisal Opening

Intervention / Treatment
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* Behavioral: exercise therapy plus jaw device
* Behavioral: exercise therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age is greater than or equal to 20 years old. Those who are able to communicate in Mandarin and Taiwanese and have no reading or listening or writing disabilities can fill out the questionnaire by themselves or with the assistance of the researcher. Diagnosed with head and neck cancer, and is expected to receive head and neck radiation therapy for the first time. A clear consciousness, no severe cognitive impairment or mental symptoms. Willing to participate in this research and obtain consent. Exclusion Criteria: People with known temporomandibular joint disorders. The maximum opening degree is less than or equal to 25 mm. Those who have received radiotherapy for the head and neck in the past. Those who have been diagnosed by a physician for poor wound healing after surgery and unable to perform mouth-opening rehabilitation exercises.

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise therapy plus jaw device<br>exercise therapy plus jaw device | Behavioral: exercise therapy plus jaw device<br>* The mouth-opening rehabilitation exercise lasts for twelve weeks, five days a week, three times a day. Subjects can arrange to perform before or after meals according to personal eating time and preferences. The experimental group performs 30 minutes each time, including 20 minutes of stretching exercises. Ten-minute mouth expander assisted passive exercise.<br>|
| Placebo Comparator: exercise therapy<br>exercise therapy | Behavioral: exercise therapy<br>* the control group performed 20-minute stretching exercises each time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of maximum interincisal opening (MIO) | Using Gothenburg Trismus Questionnaire, GTQ to measure the trismus condition and mouth opening | baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of fatigue level | using the Brief Fatigue Inventory, BFI to measure fatigue level | baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months. | 
| Quality of life (QOL) | using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Head and Neck 35-questions, EORTC-QLQ-C30-H&N35 to meaure QOL | baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trismus, head and neck cancer, radiotherapy, maximum interincisal opening