TrismusNCT04670146
Understanding Non-radiotherapy-based Development of Trismus
A study testing ultrasound of the masseteric muscle in people with Trismus and Oral Cancer, run by KU Leuven at 1 site in Belgium.
Trial summary
A limited mouth opening (or trismus) after surgery for oral cancers is not only one of the most common complications, but it is also a major contributing factor towards an impaired quality of life after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trismus, Oral Cancer
- What is being tested?
- ultrasound of the masseteric muscle
- Type of treatment
- Pill or oral medicine
- How many people
- 128 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2020to 1 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with a newly diagnosed oral cancer.
- Cases with a limited mouth opening secondary to oral tumour resections
Who cannot join
- Minors.
- Deceased cases within the follow-up period of one year.
- Other malignancies than oral squamous cell carcinomas.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Analysis of Epidemiological, Anatomical and Surgical Aspects Leading to a Limitation of the Opening of the Mouth Before and After Oral Cancer Surgery
A limited mouth opening (or trismus) after surgery for oral cancers is not only one of the most common complications, but it is also a major contributing factor towards an impaired quality of life after surgery. The enormous impact on the quality of life is secondary to impeded speech, feeding, drinking, and aesthetics.
The aim would be to analyse the opening of the mouth before and after surgery, and if applicable after radiotherapy, in a prospective way in oral cancer cases. There is namely a major discrepancy in current science research between the effect of different treatment modalities on trismus, as, in contrast with known research regarding the effect of surgery on trismus, a clear relation between radiotherapy and trismus has already been demonstrated in multiple research articles and systematic reviews. Nevertheless, the clinical experience of this research group supports the need for further investigation on the impact of surgery and the different modalities of surgery on trismus.
The investigators are convinced that revealing the surgical factors, linked with trismus, can lead to better prevention and prediction of later trismus for newly diagnosed oral cancer patients.
- Conditions
- Trismus, Oral Cancer
- Being tested
- ultrasound of the masseteric muscle
- Medical subject headings
- Trismus, Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound of the masseteric muscleDiagnostic test
Ultrasound of the masseteric muscle to evaluate the thickness and rigidity of the masseteric muscle before and after oral cancer treatment. There will be no invasive investigation of the muscle.
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of the maximal mouth opening.
A first endpoint would be to compare the effect of the epidemiological and surgical variables on the maximal mouth opening in millimeters over time.
Measured: Follow-up of twelve months.
A detailed quality of life assessment.
This research group would like to obtain a detailed image of the impact of trismus and oral cancer resections in general on the quality of life. Results will be based on validated and commonly used questionnaires addressing the different aspects of quality of life for this specific population. More specific the Washington questionnaire.
Measured: Follow-up of twelve months.
The correlation between the muscles of mastication and trismus.
Investigation of the relation between the muscles of mastication and the tumour and how this correlation influences the incidence of postsurgical trismus. Therefore, the distance between the tumor and the muscles of mastication will be evaluated in millimeters, based on 3D preoperative radiological imaging (CT or MRI).
Measured: Follow-up of twelve months.
An evaluation of the masseter muscle via ultrasound before and after oral tumor resections/trismus treatment.
The final endpoint will be the evaluation of masseter alterations on ultrasound, which will lead to an improved understanding of muscular changes due to oncological resections, radiotherapy, and trismus. Even though newer (IMRT or intensity-modulated radiation therapy) techniques in radiotherapy protect vital structures as much as possible, the masseter is still often involved in the radiated area and muscular alterations are anyhow to be expected. The endpoints will be alterations in masseter muscle thickness (millimeter) in all oral oncology cases, trismus patients secondary to oral oncology resections, and in adjuvant radiotherapy cases.
Measured: Follow-up of twelve months.
Correlation of the mouth opening with surgical variables.
The use of free vascularized grafts (primary closure/skin graft/composite grafts/soft tissue free flaps) and a neck dissection (yes/no) will be analyzed to identify an impact on the mouth opening of each surgical variable to prevent trismus in future cases. The information will be collected from the electronic patient file.
Measured: Follow-up of twelve months.
Correlation of the mouth opening with tumor stage.
The correlation between tumor stage(I-IV) (TNM-classification according to TNM-8 AJCC manual) and mouth opening will be analyzed. The information will be collected from the electronic patient file.
Measured: Follow-up of twelve months.
Correlation of the mouth opening with tumor recurrence.
An evaluation of the influence of tumor recurrence (yes/no) on the maximal mouth opening will be ordered. The information will be collected from the electronic patient file.
Measured: Follow-up of twelve months.
A detailed quality of life assessment regarding head and neck cancer treatment.
This research group would like to obtain a detailed image of the impact of trismus and oral cancer resections in general on the quality of life. Results will be based on validated and commonly used questionnaires addressing the different aspects of quality of life for this specific population. More specific the EORTC H\&N 35.
Measured: Follow-up of twelve months.
A detailed quality of life assessment regarding the mouth opening.
This research group would like to obtain a detailed image of the impact of trismus and oral cancer resections in general on the quality of life. Results will be based on validated and commonly used questionnaires addressing the different aspects of quality of life for this specific population. More specific the Gothenburg questionnaire.
Measured: Follow-up of twelve months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jul 2020
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrismusStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximiliaan Smeets, KU Leuven
- Investigators
- Michel Bila, MD, DDS, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670146
- Sponsor's protocol ID
- S63300
- Status last verified
- Dec 2020
- First submitted
- 12 Nov 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- 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 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Epidemiological, Anatomical and Surgical Aspects Leading to a Limitation of the Opening of the Mouth Before and After Oral Cancer Surgery
- ClinicalTrials.gov ID
- NCT04670146
- Acronym / sponsor ID
- S63300
- Conditions
- Trismus, Oral Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 17 Dec 2020 (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.
A limited mouth opening (or trismus) after surgery for oral cancers is not only one of the most common complications, but it is also a major contributing factor towards an impaired quality of life after surgery. The enormous impact on the quality of life is secondary to impeded speech, feeding, drinking, and aesthetics.
The aim would be to analyse the opening of the mouth before and after surgery, and if applicable after radiotherapy, in a prospective way in oral cancer cases. There is namely a major discrepancy in current science research between the effect of different treatment modalities on trismus, as, in contrast with known research regarding the effect of surgery on trismus, a clear relation between radiotherapy and trismus has already been demonstrated in multiple research articles and systematic reviews. Nevertheless, the clinical experience of this research group supports the need for further investigation on the impact of surgery and the different modalities of surgery on trismus.
The investigators are convinced that revealing the surgical factors, linked with trismus, can lead to better prevention and prediction of later trismus for newly diagnosed oral cancer patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients with a newly diagnosed oral cancer.
- Cases with a limited mouth opening secondary to oral tumour resections
Key exclusion criteria (3 listed)
- Minors.
- Deceased cases within the follow-up period of one year.
- Other malignancies than oral squamous cell carcinomas.
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 |
|---|---|---|
| ultrasound of the masseteric muscleUltrasound of the masseteric muscle to evaluate the thickness and rigidity of the masseteric muscle before and after oral cancer treatment. There will be no invasive investigation of the muscle. | Diagnostic test | – |
Primary outcome
The evaluation of the maximal mouth opening.
Time frame: Follow-up of twelve months.
A first endpoint would be to compare the effect of the epidemiological and surgical variables on the maximal mouth opening in millimeters over time.
A detailed quality of life assessment.
Time frame: Follow-up of twelve months.
This research group would like to obtain a detailed image of the impact of trismus and oral cancer resections in general on the quality of life. Results will be based on validated and commonly used questionnaires addressing the different aspects of quality of life for this specific population. More specific the Washington questionnaire.
The correlation between the muscles of mastication and trismus.
Time frame: Follow-up of twelve months.
Investigation of the relation between the muscles of mastication and the tumour and how this correlation influences the incidence of postsurgical trismus. Therefore, the distance between the tumor and the muscles of mastication will be evaluated in millimeters, based on 3D preoperative radiological imaging (CT or MRI).
An evaluation of the masseter muscle via ultrasound before and after oral tumor resections/trismus treatment.
Time frame: Follow-up of twelve months.
The final endpoint will be the evaluation of masseter alterations on ultrasound, which will lead to an improved understanding of muscular changes due to oncological resections, radiotherapy, and trismus. Even though newer (IMRT or intensity-modulated radiation therapy) techniques in radiotherapy protect vital structures as much as possible, the masseter is still often involved in the radiated area and muscular alterations are anyhow to be expected. The endpoints will be alterations in masseter muscle thickness (millimeter) in all oral oncology cases, trismus patients secondary to oral oncology resections, and in adjuvant radiotherapy cases.
Correlation of the mouth opening with surgical variables.
Time frame: Follow-up of twelve months.
The use of free vascularized grafts (primary closure/skin graft/composite grafts/soft tissue free flaps) and a neck dissection (yes/no) will be analyzed to identify an impact on the mouth opening of each surgical variable to prevent trismus in future cases. The information will be collected from the electronic patient file.
Correlation of the mouth opening with tumor stage.
Time frame: Follow-up of twelve months.
The correlation between tumor stage(I-IV) (TNM-classification according to TNM-8 AJCC manual) and mouth opening will be analyzed. The information will be collected from the electronic patient file.
Correlation of the mouth opening with tumor recurrence.
Time frame: Follow-up of twelve months.
An evaluation of the influence of tumor recurrence (yes/no) on the maximal mouth opening will be ordered. The information will be collected from the electronic patient file.
A detailed quality of life assessment regarding head and neck cancer treatment.
Time frame: Follow-up of twelve months.
This research group would like to obtain a detailed image of the impact of trismus and oral cancer resections in general on the quality of life. Results will be based on validated and commonly used questionnaires addressing the different aspects of quality of life for this specific population. More specific the EORTC H\&N 35.
A detailed quality of life assessment regarding the mouth opening.
Time frame: Follow-up of twelve months.
This research group would like to obtain a detailed image of the impact of trismus and oral cancer resections in general on the quality of life. Results will be based on validated and commonly used questionnaires addressing the different aspects of quality of life for this specific population. More specific the Gothenburg questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- 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.
Michel Bila, MD, DDS principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound of the masseteric muscle in people with Trismus and Oral Cancer, run by KU Leuven at 1 site in Belgium.
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 2 inclusion and 3 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 17 Dec 2020. 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 Belgium. 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. 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 evaluation of the maximal mouth opening. (time frame: Follow-up of twelve months.). The study lists 9 primary outcomes in all. 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 17 Dec 2020.