Closed vs. Open Face Masks for Cranial Radiotherapy

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04079595
• Other study ID #: Comfort RCT
• Status: Completed
• Phase: N/A
• Start date: December 9, 2019
• Est. completion date: May 31, 2022

Study information

• Verified date: May 2024
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 31, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Brain Tumor
• Meningioma
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

Device:
• Head immobilization mask
Immobilization

Locations

Country	Name	City	State
Switzerland	Department of Radiation Oncology	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

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

External Links

•   Randomized self-controlled study comparing open-face vs. closed immobilization masks in fractionated cranial radiotherapy