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Understanding Non-radiotherapy-based Development of Trismus

Primary Purpose

Trismus, Oral Cancer

Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
ultrasound of the masseteric muscle
Sponsored by
KU Leuven
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Trismus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients with a newly diagnosed oral cancer.
  • Cases with a limited mouth opening secondary to oral tumour resections

Exclusion Criteria:

  • Minors.
  • Deceased cases within the follow-up period of one year.
  • Other malignancies than oral squamous cell carcinomas.

Sites / Locations

  • Omfs-Impath

Outcomes

Primary Outcome Measures

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.
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.
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).
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
November 12, 2020
Last Updated
December 10, 2020
Sponsor
KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT04670146
Brief Title
Understanding Non-radiotherapy-based Development of Trismus
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trismus, Oral Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
ultrasound of the masseteric muscle
Intervention Description
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.
Primary Outcome Measure Information:
Title
The evaluation of the maximal mouth opening.
Description
A first endpoint would be to compare the effect of the epidemiological and surgical variables on the maximal mouth opening in millimeters over time.
Time Frame
Follow-up of twelve months.
Title
A detailed quality of life assessment.
Description
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.
Time Frame
Follow-up of twelve months.
Title
The correlation between the muscles of mastication and trismus.
Description
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).
Time Frame
Follow-up of twelve months.
Title
An evaluation of the masseter muscle via ultrasound before and after oral tumor resections/trismus treatment.
Description
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.
Time Frame
Follow-up of twelve months.
Title
Correlation of the mouth opening with surgical variables.
Description
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.
Time Frame
Follow-up of twelve months.
Title
Correlation of the mouth opening with tumor stage.
Description
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.
Time Frame
Follow-up of twelve months.
Title
Correlation of the mouth opening with tumor recurrence.
Description
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.
Time Frame
Follow-up of twelve months.
Title
A detailed quality of life assessment regarding head and neck cancer treatment.
Description
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.
Time Frame
Follow-up of twelve months.
Title
A detailed quality of life assessment regarding the mouth opening.
Description
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.
Time Frame
Follow-up of twelve months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients with a newly diagnosed oral cancer. Cases with a limited mouth opening secondary to oral tumour resections Exclusion Criteria: Minors. Deceased cases within the follow-up period of one year. Other malignancies than oral squamous cell carcinomas.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Bila, MD, DDS
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Omfs-Impath
City
Leuven
State/Province
Vlaams-Brabantt
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Understanding Non-radiotherapy-based Development of Trismus

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