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Comparing Radiotherapy Immobilization Systems for Anxious HNC Patients

NCT06257121 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-02-13

No results posted yet for this study

Summary

Background: Radiotherapy is a mainstay of treatment for ENT cancers, and its indication is frequent. Patients are positioned and immobilized using a thermoplastic mask, which is attached to the treatment table for the duration of each daily treatment. The mask's purpose is to prevent patient movement and ensure reproducible positioning. The advantages of using thermoplastic masks come at a cost for many patients. It is well established that mask fixation and mask anxiety are major concerns for patients, adversely affecting their quality of life and hindering treatment compliance. Surface-guided radiotherapy (SGRT) enables patients to be positioned and their movements monitored in real time during treatment. This technique has become more widely available in recent years, and is attractive because it does not involve ionizing radiation. However, although preliminary data have suggested a potential reduction in anxiety, this technique has not been evaluated for ENT RT in anxious/claustrophobic patients who cannot tolerate immobilization masks.

Objective: Investigators propose a pilot study to evaluate the feasibility and tolerability of using SGRT to manage position for patients with ENT cancer who report claustrophobia/anxiety.

Methodology: 15 participants will be recruited by the treating radiation oncologist from among patients scheduled to undergo radiation therapy at CHUM for their ENT cancer and identifying as claustrophobic/anxious. Participants who consent will be scheduled to undergo their radiotherapy using SGRT. Patients will be systematically treated with Volumetric Modulated Arc Therapy (VMAT) using SGRT on the linear accelerator with the Optical Surface Management System (OSMS) for the duration of the radiotherapy.

Measures: Patients' anxiety will be assessed using the GAD-7 and the CLQ throughout the treatment process. The feasibility and accuracy of radiotherapy treatment will be assessed using planning and daily pre-treatment examinations. In addition, skin toxicity will be assessed weekly.

Analyses: 1) Descriptive analyses, i.e. frequencies for categorical variables and means and standard deviations for continuous variables. 2) Estimation of confidence intervals.

Anticipated outcomes: Completion of this pilot project will enable investigators to plan and refine the methodological and organizational aspects for a large-scale study, i.e., a Phase III clinical trial comparing the use of SGRT with the use of a thermoplastic immobilization mask for anxious patients.

Conditions

Interventions

DEVICE

OSMS position management

Patient position management in real time during radiation using an optical Surface Management System (OSMS) (Vision RT)

Sponsors & Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Marie-Eve Pelland, Ph.D. · CHUM

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-09-01
Completion
2026-02-01

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06257121 on ClinicalTrials.gov