Closed vs. Open Face Masks for Cranial Radiotherapy

Study Overview
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Brief Summary
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The aim of the study is to evaluate whether open-face masks improve patient comfort/preference whilst maintaining immobilization performance as known for closed masks in patients undergoing whole or partial cranial radiotherapy.

Detailed Description
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Upon randomization, patients will be begin treatment either with an open-face mask (A) or closed mask (B). Two individual immobilization masks - the open-face and closed masks - will be fabricated for every single patient. During the 1st half of treatment the randomly assigned mask will be used followed by using another mask for the 2nd half of treatment. Discomfort/pain/anxiety and mask preference will be scored during treatment with a questionnaire.

Official Title
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Randomized Controlled Trial Comparing Closed vs. Open Face Masks for Cranial Radiotherapy

Conditions
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Brain Tumor, Brain Metastases, Small Cell Lung Cancer, Meningioma

Intervention / Treatment
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* Device: Head immobilization mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent according to Swiss law and International Council for Harmonization (ICH)/Good Clinical Practice (GCP) regulations before any trial specific procedures; Indication for cranial radiotherapy irrespective of tumor type; Age: ≥ 18 years old; Karnofsky performance status ≥70; Patients who are willing and able to comply with scheduled visits, treatment, and other trial procedures. Exclusion Criteria: Cranial radiotherapy in less than 10 fractions; Prior brain irradiation; Inability to complete magnetic resonance imaging (MRI) procedure due to claustrophobic anxiety; Women who are pregnant or breast feeding; Intention to become pregnant during the course of the trial; Lack of safe contraception; Known or suspected non-compliance, drug or alcohol abuse

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-faced head immonbilization masks<br>Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with openings for the face | Device: Head immobilization mask<br>* Immobilization<br>|
| Active Comparator: Closed-face head immobilization masks<br>Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with the face closed | Device: Head immobilization mask<br>* Immobilization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient discomfort with the two immobilization masks | Patient discomfort measured with the Visual Analogue Scale (VAS) 0-10 with no discomfort (scored as 0) and extreme discomfort (scored as 10). | Change in patient discomfort through the course of radiation therapy, up to 6 weeks | 
| Mask preference | Mask preference measured with the Yes/No questionnaire. Upon completion of radiation therapy patients will be asked which of the two immobilization masks they prefer - either Yes or No to one of the used masks. | At completion of radiation therapy, up to 6 weeks depending on radiation dose fractionation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment set-up accuracy | Measured with planar kilovoltage (kV) imaging | Through the course of radiation therapy, up to 6 weeks | 
| Treatment intra-fraction accuracy | Measured with an optic surface imaging (OSI) system | Through the course of radiation therapy, up to 6 weeks | 
| Immobilization-mask-induced severe adverse events during treatment | Measured with CTCAE version 5.0 | From the baseline to 3 months post-treatment | 
| Location of discomfort on the head/face | Measured with the questionnaire consisting of a head/face diagram divided in 8 regions | Changes in location of discomfort on the head/face through the course of radiation therapy up to 6 weeks |