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Clinical Trial 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05777668
Study type Observational
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact
Status Completed
Phase
Start date January 2017
Completion date October 1, 2021

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