Closed vs. Open Face Masks for Cranial Radiotherapy

Not Applicable

Completed

• Conditions: Meningioma; Brain Metastases; Small Cell Lung Cancer; Brain Tumor
• Interventions: Device: Head immobilization mask

• Registration Number: NCT04079595
• Lead Sponsor: University of Zurich

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-09-02
• Study First Posted: 2019-09-06
• Study Start: 2019-12-09
• Primary Completion: 2022-02-28
• Study Completion: 2022-05-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Open-faced head immonbilization masks	Head immobilization mask	Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with openings for the face
Closed-face head immobilization masks	Head immobilization mask	Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with the face closed

Primary Outcome Measures

Name	Time	Method
Patient discomfort with the two immobilization masks	Change in patient discomfort through the course of radiation therapy, up to 6 weeks	Patient discomfort measured with the Visual Analogue Scale (VAS) 0-10 with "no discomfort" (scored as 0) and "extreme discomfort" (scored as 10).
Mask preference	At completion of radiation therapy, up to 6 weeks depending on radiation dose fractionation	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Radiation Oncology; 🇨🇭 Zürich, Switzerland