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Brief Title: A Predictive Nomogram for Trismus After Radiotherapy for Head and Neck Cancer
Official Title: A Predictive Nomogram for Trismus After Radiotherapy for Head and Neck Cancer
Study ID: NCT05777668
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
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Name: Mariangela Massaccesi, MD
Affiliation: Fondazione Policlinico Universitario Agostino Gemelli
Role: PRINCIPAL_INVESTIGATOR