Brain TumorNCT04079595
Closed vs. Open Face Masks for Cranial Radiotherapy
A study testing Head immobilization mask in people with Brain Tumor and Brain Metastases, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor, Brain Metastases, Small Cell Lung Cancer
- What is being tested?
- Head immobilization mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Dec 2019to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Tumor, Brain Metastases, Small Cell Lung Cancer, Meningioma
- Being tested
- Head immobilization mask
- Medical subject headings
- Brain Neoplasms, Small Cell Lung Carcinoma, Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head immobilization maskDevice
Immobilization
| Study group | Role | What they receive |
|---|---|---|
| Open-faced head immonbilization masks | Experimental | Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with openings for the face Receives: Device: Head immobilization mask |
| Closed-face head immobilization masks | Active comparator | Masks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with the face closed Receives: Device: Head immobilization mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: At completion of radiation therapy, up to 6 weeks depending on radiation dose fractionation
Secondary outcomes (4)
Treatment set-up accuracy
Measured with planar kilovoltage (kV) imaging
Measured: Through the course of radiation therapy, up to 6 weeks
Treatment intra-fraction accuracy
Measured with an optic surface imaging (OSI) system
Measured: Through the course of radiation therapy, up to 6 weeks
Immobilization-mask-induced severe adverse events during treatment
Measured with CTCAE version 5.0
Measured: 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
Measured: Changes in location of discomfort on the head/face through the course of radiation therapy up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start9 Dec 2019
- Primary completion28 Feb 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Guckenberger, Dr., Principal investigator, University Hospital Zurich, Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079595
- Sponsor's protocol ID
- Comfort RCT
- Status last verified
- May 2024
- First submitted
- 11 Jul 2019
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Closed vs. Open Face Masks for Cranial Radiotherapy
- ClinicalTrials.gov ID
- NCT04079595
- Acronym / sponsor ID
- Comfort RCT
- Conditions
- Brain Tumor, Brain Metastases, Small Cell Lung Cancer, Meningioma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open-faced head immonbilization masks | Experimental | Device: Head immobilization maskMasks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with openings for the face |
| Closed-face head immobilization masks | Active comparator | Device: Head immobilization maskMasks used for immobilization of the head (CIVCO Radiotherapy, Orange City, Iowa) during radiation therapy with the face closed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head immobilization maskImmobilization | Device | Closed-face head immobilization masks, Open-faced head immonbilization masks |
Primary outcome
Patient discomfort with the two immobilization masks
Time frame: 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
Time frame: 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.
4 secondary outcomes
Treatment set-up accuracy
Time frame: Through the course of radiation therapy, up to 6 weeks
Treatment intra-fraction accuracy
Time frame: Through the course of radiation therapy, up to 6 weeks
Immobilization-mask-induced severe adverse events during treatment
Time frame: From the baseline to 3 months post-treatment
Location of discomfort on the head/face
Time frame: Changes in location of discomfort on the head/face through the course of radiation therapy up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Randomized self-controlled study comparing open-face vs. closed immobilization masks in fractionated cranial radiotherapyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Guckenberger, Dr. principal investigator
University Hospital Zurich, Department of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head immobilization mask in people with Brain Tumor and Brain Metastases, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient discomfort with the two immobilization masks (time frame: Change in patient discomfort through the course of radiation therapy, up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.