Closed vs. Open Face Masks for Cranial Radiotherapy

University of Zurich60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Brain Tumor Brain Metastases Small Cell Lung Cancer Meningioma

Interventions

Head immobilization maskDEVICE

Immobilization

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Radiation Oncology

Zurich, Switzerland

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: At completion of radiation therapy, up to 6 weeks depending on radiation dose fractionation

Secondary Outcomes

Treatment set-up accuracy

Measured with planar kilovoltage (kV) imaging

Time frame: Through the course of radiation therapy, up to 6 weeks

Treatment intra-fraction accuracy

Measured with an optic surface imaging (OSI) system

Time frame: Through the course of radiation therapy, up to 6 weeks

Immobilization-mask-induced severe adverse events during treatment

Measured with CTCAE version 5.0

Time frame: 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

Time frame: Changes in location of discomfort on the head/face through the course of radiation therapy up to 6 weeks

Data from ClinicalTrials.gov

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