NCT04740216

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Taipei Medical University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Maximum Interincisal Opening

Interventions

Type	Name	Description
BEHAVIORAL	exercise therapy plus jaw device	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.
BEHAVIORAL	exercise therapy	the control group performed 20-minute stretching exercises each time.

Timeline

• Start date: 2021-02-10
• Primary completion: 2023-02-10
• Completion: 2023-06-30
• First posted: 2021-02-05
• Last updated: 2021-02-05