A Predictive Nomogram for Trismus After Radiotherapy for Head and Neck Cancer

Completed

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Head and neck cancer patients undergoing radiotherapy	Volumetric modulated radiotherapy	-

Primary Outcome Measures

Name	Time	Method
Trismus	6 months	maximal interincisal distance equal to or less than 35 mm

Secondary Outcome Measures

Name	Time	Method

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