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

Sponsor

Taipei Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04740216

Collaborator

(none)

130

Enrollment

Arms

28.6

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Maximum Interincisal Opening	Behavioral: exercise therapy plus jaw device Behavioral: exercise therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Feb 10, 2021

Anticipated Primary Completion Date :

Feb 10, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: exercise therapy plus jaw device exercise therapy plus jaw device	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.
Placebo Comparator: exercise therapy exercise therapy	Behavioral: exercise therapy the control group performed 20-minute stretching exercises each time.

Arm

Intervention/Treatment

Experimental: exercise therapy plus jaw device

exercise therapy plus jaw device

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.

Placebo Comparator: exercise therapy

exercise therapy

Behavioral: exercise therapy

the control group performed 20-minute stretching exercises each time.

Outcome Measures

Primary Outcome Measures

The change of maximum interincisal opening (MIO) [baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.]
Using Gothenburg Trismus Questionnaire, GTQ to measure the trismus condition and mouth opening

Secondary Outcome Measures

The change of fatigue level [baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.]
using the Brief Fatigue Inventory, BFI to measure fatigue level
Quality of life (QOL) [baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.