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

Maximum Interincisal Opening Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04740216
• Other study ID #: B202005159
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: February 2021
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: June 30, 2023
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Age is greater than or equal to 20 years old.

2. 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.

3. Diagnosed with head and neck cancer, and is expected to receive head and neck radiation therapy for the first time.

4. A clear consciousness, no severe cognitive impairment or mental symptoms.

5. Willing to participate in this research and obtain consent.

Exclusion Criteria:

1. People with known temporomandibular joint disorders.

2. The maximum opening degree is less than or equal to 25 mm.

3. Those who have received radiotherapy for the head and neck in the past.

4. Those who have been diagnosed by a physician for poor wound healing after surgery and unable to perform mouth-opening rehabilitation exercises.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Maximum Interincisal Opening
• Trismus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.