Closed vs. Open Face Masks for Cranial Radiotherapy

Sponsor

University of Zurich (Other)

Overall Status

Recruiting

CT.gov ID

NCT04079595

Collaborator

(none)

Enrollment

Location

Arms

9.7

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Tumor Brain Metastases Small Cell Lung Cancer Meningioma	Device: Head immobilization mask	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 9, 2019

Anticipated Primary Completion Date :

Sep 30, 2020

Anticipated Study Completion Date :

Sep 30, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Treatment set-up accuracy [Through the course of radiation therapy, up to 6 weeks]
Measured with planar kilovoltage (kV) imaging
Treatment intra-fraction accuracy [Through the course of radiation therapy, up to 6 weeks]
Measured with an optic surface imaging (OSI) system
Immobilization-mask-induced severe adverse events during treatment [From the baseline to 3 months post-treatment]
Measured with CTCAE version 5.0
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Radiation Oncology	Zürich		Switzerland	8091

Sponsors and Collaborators

University of Zurich

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Zurich

ClinicalTrials.gov Identifier:

NCT04079595

Other Study ID Numbers:

Comfort RCT

First Posted:

Sep 6, 2019

Last Update Posted:

Oct 5, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Small Cell Lung Carcinoma

Brain Neoplasms

Meningioma

Study Results

No Results Posted as of Oct 5, 2020