Effects of Exercise Therapy Adjuvant Device on Head and Neck Cancer Patients in the Treatment of Cancer Therapy Induced Trismus
Primary Purpose
Maximum Interincisal Opening
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercise therapy plus jaw device
exercise therapy
Sponsored by
About this trial
This is an interventional treatment trial for Maximum Interincisal Opening focused on measuring trismus, head and neck cancer, radiotherapy, maximum interincisal opening
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
exercise therapy plus jaw device
exercise therapy
Arm Description
exercise therapy plus jaw device
exercise therapy
Outcomes
Primary Outcome Measures
The change of maximum interincisal opening (MIO)
Using Gothenburg Trismus Questionnaire, GTQ to measure the trismus condition and mouth opening
Secondary Outcome Measures
The change of fatigue level
using the Brief Fatigue Inventory, BFI to measure fatigue level
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
Full Information
NCT ID
NCT04740216
First Posted
February 2, 2021
Last Updated
February 4, 2021
Sponsor
Taipei Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04740216
Brief Title
Effects of Exercise Therapy Adjuvant Device on Head and Neck Cancer Patients in the Treatment of Cancer Therapy Induced Trismus
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2021 (Anticipated)
Primary Completion Date
February 10, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maximum Interincisal Opening
Keywords
trismus, head and neck cancer, radiotherapy, maximum interincisal opening
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
exercise therapy plus jaw device
Arm Type
Experimental
Arm Description
exercise therapy plus jaw device
Arm Title
exercise therapy
Arm Type
Placebo Comparator
Arm Description
exercise therapy
Intervention Type
Behavioral
Intervention Name(s)
exercise therapy plus jaw device
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
exercise therapy
Intervention Description
the control group performed 20-minute stretching exercises each time.
Primary Outcome Measure Information:
Title
The change of maximum interincisal opening (MIO)
Description
Using Gothenburg Trismus Questionnaire, GTQ to measure the trismus condition and mouth opening
Time Frame
baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.
Secondary Outcome Measure Information:
Title
The change of fatigue level
Description
using the Brief Fatigue Inventory, BFI to measure fatigue level
Time Frame
baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.
Title
Quality of life (QOL)
Description
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
Time Frame
baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Effects of Exercise Therapy Adjuvant Device on Head and Neck Cancer Patients in the Treatment of Cancer Therapy Induced Trismus
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