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

NCT ID: NCT05777668

Last Updated: 2023-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2021-10-01

Brief Summary

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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.

Detailed Description

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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

Conditions

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Trismus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Head and neck cancer patients undergoing radiotherapy

Volumetric modulated radiotherapy

Intervention Type RADIATION

Interventions

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Volumetric modulated radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariangela Massaccesi, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario Agostino Gemelli

Other Identifiers

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4641

Identifier Type: -

Identifier Source: org_study_id

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