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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Completed

CT.gov ID

NCT05777668

Collaborator

(none)

104

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Trismus	Radiation: Volumetric modulated radiotherapy

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

Study Design

Study Type:

Observational

Actual Enrollment :

104 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Apr 1, 2021

Actual Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Head and neck cancer patients undergoing radiotherapy	Radiation: Volumetric modulated radiotherapy

Arm

Intervention/Treatment

Head and neck cancer patients undergoing radiotherapy

Radiation: Volumetric modulated radiotherapy

Outcome Measures

Primary Outcome Measures

Trismus [6 months]
maximal interincisal distance equal to or less than 35 mm

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

Principal Investigator: Mariangela Massaccesi, MD, Fondazione Policlinico Universitario Agostino Gemelli

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT05777668

Other Study ID Numbers:

4641

First Posted:

Mar 21, 2023

Last Update Posted:

Mar 21, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS

radiation induced trismus, head and neck radiotherapy

Additional relevant MeSH terms:

Head and Neck Neoplasms

Trismus

Study Results

No Results Posted as of Mar 21, 2023