An observational study in Trismus, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Completed. Per ClinicalTrials.gov, last updated 2023-03-21.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
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
107 studies on the registry are indexed under Trismus; 19 are open to participants now.
Browse Trismus studies →Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 952 studies on the registry; 541 are open to participants now.
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patients with HNC treated consecutively with definitive or postoperative external beam radiotherapy, either alone or in combination with chemotherapy or cetuximab, between January 2017 and April 2021 at Gemelli Advanced Radiation Therapy (ART) center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Exclusion Criteria:
Radiation: Volumetric modulated radiotherapy
Trismus
maximal interincisal distance equal to or less than 35 mm
Time frame: 6 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in Apr 2021, 51 months.
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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