Head and Neck CancersET-JMD for TriNCT06719388
Exercise Therapy and Jaw-Mobilizing Device for Trismus in Head and Neck Cancer Patients
A study testing combination of exercise therapy and a jaw-mobilizing device and exercise therapy only in people with Head and Neck Cancers and Trismus, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
This study evaluates the effects of exercise therapy combined with a jaw-mobilizing device on enhancing quality of life in head and neck cancer patients undergoing radiotherapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Head and Neck Cancers, Trismus, Radiotherapy Side Effects
- What is being tested?
- combination of exercise therapy and a jaw-mobilizing device and exercise therapy only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2021to 31 Oct 2024
- 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 ≥ 20 years.
- Ability to communicate in Mandarin or Taiwanese, without significant reading, hearing, or writing impairments, and capable of completing questionnaires independently or with researcher assistance.
- Diagnosed with head and neck cancer and scheduled for initial radiotherapy to the head and neck region.
- Clear consciousness without severe cognitive or psychiatric disorders.
- Presence of intact central incisors (#11, #41) on the right side or (#21, #31) on the left side of both the upper and lower jaws.
- Baseline maximal mouth opening (MMO) ≥ 25 mm.
- Willingness to participate in the study with signed informed consent.
Who cannot join
- Known temporomandibular joint disorders.
- Postoperative wound healing complications diagnosed by a physician that prevent participation in mouth-opening rehabilitation exercises.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Therapy Combined with a Jaw-Mobilizing Device for Improving Maximal Mouth Opening and Trismus in Patients with Head and Neck Cancer: a Randomized Controlled Trial
This study evaluates the effects of exercise therapy combined with a jaw-mobilizing device on enhancing quality of life in head and neck cancer patients undergoing radiotherapy.
Read the detailed description
This study investigates the efficacy of exercise therapy combined with a jaw-mobilizing device (ET-JMD) in improving maximal mouth opening (MMO), preventing trismus, enhancing quality of life (QoL), and alleviating trismus-related symptoms in head and neck cancer (HNC) patients undergoing radiotherapy.
- Conditions
- Head and Neck Cancers, Trismus, Radiotherapy Side Effects
- Being tested
- combination of exercise therapy and a jaw-mobilizing device, exercise therapy only
- Keywords
- Head and Neck Cancer, Trismus, Radiotherapy-Induced Mouth Opening Limitation
- Medical subject headings
- Head and Neck Neoplasms, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of exercise therapy and a jaw-mobilizing deviceBehavioural
Participants in the experimental group will receive a combination of exercise therapy and a jaw-mobilizing device. The intervention includes structured exercise therapy sessions and the use of the jaw-mobilizing device for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes.
exercise therapy onlyBehavioural
Participants in the control group will receive exercise therapy only. This intervention involves the same structured exercise therapy sessions as the experimental group for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in the experimental group will receive a combination of exercise therapy and a jaw-mobilizing device. The intervention includes structured exercise therapy sessions and the use of the jaw-mobilizing device for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes. Receives: Behavioral: combination of exercise therapy and a jaw-mobilizing device |
| Control Group | Placebo comparator | Participants in the control group will receive exercise therapy only. This intervention involves the same structured exercise therapy sessions as the experimental group for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes. Receives: Behavioral: exercise therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Mouth Opening
Change in Maximal Mouth Opening (MMO) from Baseline to Week 36. higher score means worse.
Measured: Baseline to Week 36
Secondary outcomes (2)
Quality of Life Scores
Change in Quality of Life Scores (EORTC QLQ-H\&N35) from Baseline to Week 36. higher score means good quality.
Measured: Baseline to Week 36
Trismus-Related Symptom Distress Scores
Change in Trismus-Related Symptom Distress Scores (GTQ2) from Baseline to Week 36. higher score means worse.
Measured: Baseline to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start1 Dec 2021
- Primary completion30 Jun 2023
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancersStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two parallel groups: the experimental group, which receives exercise therapy combined with a jaw-mobilizing device, or the control group, which receives exercise therapy only. Both groups are followed concurrently throughout the study period.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
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
- NCT06719388
- Sponsor's protocol ID
- Jaw-Mobilizing Device
- Acronym
- ET-JMD for Tri
- Status last verified
- Dec 2024
- First submitted
- 28 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Therapy Combined with a Jaw-Mobilizing Device for Improving Maximal Mouth Opening and Trismus in Patients with Head and Neck Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06719388
- Acronym / sponsor ID
- ET-JMD for Tri / Jaw-Mobilizing Device
- Conditions
- Head and Neck Cancers, Trismus, Radiotherapy Side Effects
- Keywords
- Head and Neck Cancer, Trismus, Radiotherapy-Induced Mouth Opening Limitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 5 Dec 2024 (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.
This study evaluates the effects of exercise therapy combined with a jaw-mobilizing device on enhancing quality of life in head and neck cancer patients undergoing radiotherapy.
Detailed description
This study investigates the efficacy of exercise therapy combined with a jaw-mobilizing device (ET-JMD) in improving maximal mouth opening (MMO), preventing trismus, enhancing quality of life (QoL), and alleviating trismus-related symptoms in head and neck cancer (HNC) patients undergoing radiotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two parallel groups: the experimental group, which receives exercise therapy combined with a jaw-mobilizing device, or the control group, which receives exercise therapy only. Both groups are followed concurrently throughout the study period.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: combination of exercise therapy and a jaw-mobilizing deviceParticipants in the experimental group will receive a combination of exercise therapy and a jaw-mobilizing device. The intervention includes structured exercise therapy sessions and the use of the jaw-mobilizing device for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes. |
| Control Group | Placebo comparator | Behavioral: exercise therapy onlyParticipants in the control group will receive exercise therapy only. This intervention involves the same structured exercise therapy sessions as the experimental group for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 20 years.
- Ability to communicate in Mandarin or Taiwanese, without significant reading, hearing, or writing impairments, and capable of completing questionnaires independently or with researcher assistance.
- Diagnosed with head and neck cancer and scheduled for initial radiotherapy to the head and neck region.
- Clear consciousness without severe cognitive or psychiatric disorders.
- Presence of intact central incisors (#11, #41) on the right side or (#21, #31) on the left side of both the upper and lower jaws.
Key exclusion criteria (2 listed)
- Known temporomandibular joint disorders.
- Postoperative wound healing complications diagnosed by a physician that prevent participation in 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 |
|---|---|---|
| combination of exercise therapy and a jaw-mobilizing deviceParticipants in the experimental group will receive a combination of exercise therapy and a jaw-mobilizing device. The intervention includes structured exercise therapy sessions and the use of the jaw-mobilizing device for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes. | Behavioural | Experimental Group |
| exercise therapy onlyParticipants in the control group will receive exercise therapy only. This intervention involves the same structured exercise therapy sessions as the experimental group for 12 weeks, beginning one week prior to radiotherapy. Follow-ups will occur at weeks 16, 24, and 36 to assess outcomes. | Behavioural | Control Group |
Primary outcome
Maximal Mouth Opening
Time frame: Baseline to Week 36
Change in Maximal Mouth Opening (MMO) from Baseline to Week 36. higher score means worse.
2 secondary outcomes
Quality of Life Scores
Time frame: Baseline to Week 36
Trismus-Related Symptom Distress Scores
Time frame: Baseline to Week 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combination of exercise therapy and a jaw-mobilizing device and exercise therapy only in people with Head and Neck Cancers and Trismus, run by Taipei Medical University at 1 site in Taiwan.
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximal Mouth Opening (time frame: Baseline to Week 36). 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 Dec 2024.