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

March 9, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trismus
Time Frame: 6 months
maximal interincisal distance equal to or less than 35 mm
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

October 1, 2021

Study Registration Dates

First Submitted

March 9, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4641

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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