Trials / Completed
CompletedNCT05777668
A Predictive Nomogram for Trismus After Radiotherapy for Head and Neck Cancer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 104 (actual)
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Volumetric modulated radiotherapy |
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2021-04-01
- Completion
- 2021-10-01
- First posted
- 2023-03-21
- Last updated
- 2023-03-21
Source: ClinicalTrials.gov record NCT05777668. Inclusion in this directory is not an endorsement.