Maximum Interincisal OpeningNCT04740216
Effects of Exercise Therapy Adjuvant Device on Head and Neck Cancer Patients in the Treatment of Cancer Therapy Induced Trismus
A study testing exercise therapy plus jaw device and exercise therapy in people with Maximum Interincisal Opening, run by Taipei Medical University.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Maximum Interincisal Opening
- What is being tested?
- exercise therapy plus jaw device and exercise therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 10 Feb 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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
- Being tested
- exercise therapy plus jaw device, exercise therapy
- Keywords
- trismus, head and neck cancer, radiotherapy, maximum interincisal opening
- Medical subject headings
- Trismus, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise therapy plus jaw deviceBehavioural
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 therapyBehavioural
the control group performed 20-minute stretching exercises each time.
| Study group | Role | What they receive |
|---|---|---|
| exercise therapy plus jaw device | Experimental | exercise therapy plus jaw device Receives: Behavioral: exercise therapy plus jaw device |
| exercise therapy | Placebo comparator | exercise therapy Receives: Behavioral: exercise therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of maximum interincisal opening (MIO)
Using Gothenburg Trismus Questionnaire, GTQ to measure the trismus condition and mouth opening
Measured: baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.
Secondary outcomes (2)
The change of fatigue level
using the Brief Fatigue Inventory, BFI to measure fatigue level
Measured: 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
Measured: baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start10 Feb 2021 (estimated)
- Primary completion10 Feb 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maximum Interincisal OpeningStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tsai-Wei Huang, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740216
- Sponsor's protocol ID
- B202005159
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04740216
- Acronym / sponsor ID
- B202005159
- Conditions
- Maximum Interincisal Opening
- Keywords
- trismus, head and neck cancer, radiotherapy, maximum interincisal opening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 10 Feb 2021 (estimated)
- Primary completion
- 10 Feb 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 5 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise therapy plus jaw device | Experimental | Behavioral: exercise therapy plus jaw deviceexercise therapy plus jaw device |
| exercise therapy | Placebo comparator | Behavioral: exercise therapyexercise therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise therapy plus jaw deviceThe 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. | Behavioural | exercise therapy plus jaw device |
| exercise therapythe control group performed 20-minute stretching exercises each time. | Behavioural | exercise therapy |
Primary outcome
The change of maximum interincisal opening (MIO)
Time frame: 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
2 secondary outcomes
The change of fatigue level
Time frame: baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.
Quality of life (QOL)
Time frame: baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
Related trials for Maximum Interincisal Opening
Not yet recruiting
Autologous PRP Versus Triamcinolone Acetate in Patients With Oral Submucous Fibrosis
Oral Submucous Fibrosis
Not yet recruiting
A Feasibility Study of AI-Assisted Physiotherapy for Oral Cancer Patients
AI (Artificial Intelligence), Oral Cancer
RecruitingObservational study
Relationship Between Mouth Opening and Masseter Elasticity in Oral Cancer
Oral Cancer
RecruitingObservational study
AI-based Physiotherapy Evaluation System for Range of Motion in Oral Cancer Patients
Oral Cancer, AI (Artificial Intelligence)
Recruiting
AI-based Physiotherapy for Oral Cancer Patients
Oral Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing exercise therapy plus jaw device and exercise therapy in people with Maximum Interincisal Opening, run by Taipei Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of maximum interincisal opening (MIO) (time frame: baseline, 2 weeks, 4 weeks, 6 weeks, 8weeks, 10 weeks, 12 weeks, 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.