Clinical trial NCT04670146: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Trismus
Oral Cancer
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: The evaluation of the maximal mouth opening.
timeFrame: Follow-up of twelve months.
measure: A detailed quality of life assessment.
timeFrame: Follow-up of twelve months.
measure: The correlation between the muscles of mastication and trismus.
timeFrame: Follow-up of twelve months.
measure: An evaluation of the masseter muscle via ultrasound before and after oral tumor resections/trismus treatment.
timeFrame: Follow-up of twelve months.
measure: Correlation of the mouth opening with surgical variables.
timeFrame: Follow-up of twelve months.
measure: Correlation of the mouth opening with tumor stage.
timeFrame: Follow-up of twelve months.
measure: Correlation of the mouth opening with tumor recurrence.
timeFrame: Follow-up of twelve months.
measure: A detailed quality of life assessment regarding head and neck cancer treatment.
timeFrame: Follow-up of twelve months.
measure: A detailed quality of life assessment regarding the mouth opening.
timeFrame: Follow-up of twelve months.
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Omfs-Impath
state: Vlaams-Brabantt
Study officials:
affiliation: KU Leuven
name: Michel Bila, MD, DDS
role: PRINCIPAL_INVESTIGATOR
References: