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NCT05777668 Clinical Trial

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

Trismus Clinical Trial

Official title:
A Predictive Nomogram for Trismus After Radiotherapy for Head and Neck Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05777668
Other study ID # 4641
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date October 1, 2021

Study information
Verified date March 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.

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 information / eligibility
Status Completed
Enrollment 104
Est. completion date October 1, 2021
Est. primary completion date April 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
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

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Volumetric modulated radiotherapy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome
Type Measure Description Time frame Safety issue
Primary Trismus maximal interincisal distance equal to or less than 35 mm 6 months
See also
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Completed NCT03690167 - Investigation of the Effects of CGF and A-PRF on Pain, Edema and Trismus After Impacted Lower Third Molar Surgery N/A
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