Closed vs. Open Face Masks for Cranial Radiotherapy

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

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.

Study Overview

• Status: Unknown
• Conditions: Small Cell Lung Cancer; Brain Tumor; Meningioma; Brain Metastases
• Intervention / Treatment: Device: Head immobilization mask

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthias Guckenberger, Dr.; Phone Number: +41 44 255 29 30; Email: matthias.guckenberger@usz.ch

Study Locations

• Switzerland
  • Zürich, Switzerland, 8091
    • Recruiting
    • Department of Radiation Oncology
    • Contact: Michelle Brown, Dr.; Phone Number: +41 44 255 35 67; Email: michelleleanne.brown@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Open-faced head immonbilization masks; Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with openings for the face	Device: Head immobilization mask; Immobilization
ACTIVE_COMPARATOR: Closed-face head immobilization masks; Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with the face closed	Device: Head immobilization mask; Immobilization

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Matthias Guckenberger, Dr., University Hospital Zurich, Department of Radiation Oncology

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 9, 2019
• Primary Completion (ANTICIPATED): September 30, 2020
• Study Completion (ANTICIPATED): September 30, 2020

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: September 2, 2019
• First Posted (ACTUAL): September 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Lung Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Small Cell Lung Carcinoma; Brain Neoplasms; Meningioma
• Other Study ID Numbers: Comfort RCT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No