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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06257121
Other study ID # 2024-11940
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date February 1, 2026

Study information

Verified date February 2024
Source Centre hospitalier de l'Université de Montréal (CHUM)
Contact Mom Phat, RN
Phone 514-890-8000
Email mom.phat.chum@ssss.gouv.qc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15
Est. completion date February 1, 2026
Est. primary completion date September 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Eighteen years of age or older - Able to fluently speak, read and write French or English - Histologically confirmed head and neck cancer - Patients treated with radiotherapy as primary treatment - Identified as having moderate mask anxiety / claustrophobia (i.e. a score of 10 or more on the Generalized Anxiety Disorder 7 item (GAD-7) questionnaire and / or a score of 28 or more on the Claustrophobia questionnaire (CLQ) suffocation subscale and / a score of 24 or more on the CLQ restriction subscale - An Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0-2 - Able to understand and sign consent form - Patients must be willing to comply with treatment plan and other study procedures Exclusion Criteria: - Patients with significantly altered mental status or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study - Patients who cannot stay still during fraction because of a disorder (e.g., Parkinson's disease)

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Outcome

Type Measure Description Time frame Safety issue
Primary Anxiety questionnaire Generalized Anxiety Disorder Questionnaire (GAD-7), GAD-7 total score for the seven items ranges from 0 to 21. Higher score indicates worse outcome. weekly from baseline to last week of treatment
Primary Anxiety behavior Behavioral assessments of anxiety: (a) use of psychoactive (anxiolytic) medication; (b) use of psychological interventions / strategies (exposure therapy, relaxation / meditation, etc.); (c) use of music in treatment room; (d) need for vocal reassurance by technologists during scan/MRI; (e) exam interruptions weekly from baseline to end of radiation therapy, an average of 7 weeks
Primary Claustrophobia Claustrophobia Questionnaire (CLQ), includes two subscales of 14 and 12 items, total scores range from 0 to 104. Higher score indicates worse outcome. weekly from baseline to end of radiation therapy, an average of 7 weeks
Secondary Well-being Functional Assessment of Cancer Therapy scale (FACT-G7). Total score for seven items ranges from 0 to 28. Higher score indicates better outcome. weekly from baseline to end of radiation therapy, an average of 7 weeks
Secondary Setup consistency Setup consistency between consecutive treatment planning scans Once - at treatment planning, on average 2 weeks after baseline
Secondary Intrafraction setup consistency Intrafraction setup consistency as reported by the surface guidance system (total amplitude & max deviation over time) Daily from first to last radiotherapy treatment fraction, an average 7 weeks.
Secondary Fraction time Daily total fraction time as recorded Daily from first to last radiotherapy treatment fraction, an average 7 weeks.
Secondary Skin toxicity Skin toxicity grade assessed by treating rdio-oncologist at weekly follow-up weekly from baseline to end of radiation therapy, an average of 7 weeks
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