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Closed vs. Open Face Masks for Cranial Radiotherapy

Primary Purpose

Brain Tumor, Brain Metastases, Small Cell Lung Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Head immobilization mask
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Brain Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Radiation OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Open-faced head immonbilization masks

Closed-face head immobilization masks

Arm Description

Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with openings for the face

Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with the face closed

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Treatment set-up accuracy
Measured with planar kilovoltage (kV) imaging
Treatment intra-fraction accuracy
Measured with an optic surface imaging (OSI) system
Immobilization-mask-induced severe adverse events during treatment
Measured with CTCAE version 5.0
Location of discomfort on the head/face
Measured with the questionnaire consisting of a head/face diagram divided in 8 regions

Full Information

First Posted
July 11, 2019
Last Updated
October 1, 2020
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT04079595
Brief Title
Closed vs. Open Face Masks for Cranial Radiotherapy
Official Title
Randomized Controlled Trial Comparing Closed vs. Open Face Masks for Cranial Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 9, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor, Brain Metastases, Small Cell Lung Cancer, Meningioma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open-faced head immonbilization masks
Arm Type
Experimental
Arm Description
Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with openings for the face
Arm Title
Closed-face head immobilization masks
Arm Type
Active Comparator
Arm Description
Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with the face closed
Intervention Type
Device
Intervention Name(s)
Head immobilization mask
Intervention Description
Immobilization
Primary Outcome Measure Information:
Title
Patient discomfort with the two immobilization masks
Description
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
Title
Mask preference
Description
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 Outcome Measure Information:
Title
Treatment set-up accuracy
Description
Measured with planar kilovoltage (kV) imaging
Time Frame
Through the course of radiation therapy, up to 6 weeks
Title
Treatment intra-fraction accuracy
Description
Measured with an optic surface imaging (OSI) system
Time Frame
Through the course of radiation therapy, up to 6 weeks
Title
Immobilization-mask-induced severe adverse events during treatment
Description
Measured with CTCAE version 5.0
Time Frame
From the baseline to 3 months post-treatment
Title
Location of discomfort on the head/face
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthias Guckenberger, Dr.
Phone
+41 44 255 29 30
Email
matthias.guckenberger@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Guckenberger, Dr.
Organizational Affiliation
University Hospital Zurich, Department of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Radiation Oncology
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Brown, Dr.
Phone
+41 44 255 35 67
Email
michelleleanne.brown@usz.ch

12. IPD Sharing Statement

Plan to Share IPD
No

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Closed vs. Open Face Masks for Cranial Radiotherapy

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