NCT05777668

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

4.2 years

First QC Date

March 9, 2023

Last Update Submit

March 9, 2023

Conditions

Trismus

Keywords

radiation induced trismus, head and neck radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Trismus

    maximal interincisal distance equal to or less than 35 mm

    6 months

Study Arms (1)

Head and neck cancer patients undergoing radiotherapy

Radiation: Volumetric modulated radiotherapy

Interventions

Volumetric modulated radiotherapyRADIATION
Head and neck cancer patients undergoing radiotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • HNC
  • treatment definitive or postoperative external beam radiotherapy, either alone or in -combination with chemotherapy or cetuximab at least 6 months follow-up

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Trismus

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

SpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Mariangela Massaccesi, MD

    Fondazione Policlinico Universitario Agostino Gemelli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 21, 2023

Study Start

January 1, 2017

Primary Completion

April 1, 2021

Study Completion

October 1, 2021

Last Updated

March 21, 2023

Record last verified: 2023-03