Trismus
Conditions
Keywords
radiation induced trismus, head and neck radiotherapy
Brief summary
Background: The aim of this study is to develop a prediction model for radiation-induced trismus (maximal interincisal distance equal to or less than 35 mm) based on a multivariable analysis of dosimetric and clinical factors.
Detailed description
The maximum inter-incisal opening (MIO) of hean and neck cancer (HNC) patients who undergo radiotherapy (RT) ± concurrent chemotherapy with radical intent, will be prospectively measured prior to RT (baseline) and 6 months post-RT. The potential risk factors (clinical and dosimetric) will be first screened by univariate analysis and then by multivariate analysis. At the end of this process, the features identified as relevant, will be used to fit a logistic regression model and calculate the probability of observed trismus during the 6-month follow-up after RT
Interventions
RADIATIONVolumetric modulated radiotherapy
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* HNC * treatment definitive or postoperative external beam radiotherapy, either alone or in -combination with chemotherapy or cetuximab at least 6 months follow-up
Exclusion criteria
* primary tumor out-side the head and neck region, intracranially, or if it originated from the nasal vestibule * patient death during RT or within the first 6 months after the start of RT, no outcome data available
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Trismus | 6 months | maximal interincisal distance equal to or less than 35 mm |
Outcome results
None listed