Head and Neck CancersNoMaskNCT06870799
Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy
A study testing Surface guided radiation therapy and Closed face mask in people with Head and Neck Cancers, run by University of Zurich at 1 site in Switzerland.
Trial summary
At present, open-face masks are used only in patients with claustrophobic anxiety, while all other patients are still immobilized with closed masks, thereby overlooking the need for improvement in patient comfort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancers
- What is being tested?
- Surface guided radiation therapy and Closed face mask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 May 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 ICH/GCP regulations before any trial specific procedures;
- Indication for head and neck 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
- Prior head and neck irradiation;
- Women who are pregnant or breast feeding;
- Intention to become pregnant during the course of the trial;
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases;
- Known or suspected non-compliance, drug or alcohol abuse;
- Inability to follow the procedures of the trial, e.g. due to language problems of the participant;
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
- One of the following Tumor Types: Nasopharynx, Sinunasal, patients with CTV within 5 mm of eyes or spinal cord.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Crystal Sulaiman contact
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Zurich
Zurich, 8091
Panagiotis Balermpas, Prof. Dr., panagiotis.balermpas@usz.ch
About this study
Official title: Randomized Controlled Trial Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy
At present, open-face masks are used only in patients with claustrophobic anxiety, while all other patients are still immobilized with closed masks, thereby overlooking the need for improvement in patient comfort. Closed face masks in patients undergoing head and neck irradiation have never been compared to no masks in the setting of a randomized clinical trial, but only in feasibility trials. A randomized clinical trial may establish the role of no masks in terms of patient comfort, preference and setup accuracy in all patients.
Read the detailed description
Once eligibility has been confirmed and upon randomization, patients will begin treatment either with an immobilization mask (A) or no mask (B). One individual immobilization mask and AccuForm cushion will be fabricated for every single patient. All positioning setup information used for subsequent treatment sessions will be documented. One simulation CT/MRI will be acquired and one treatment plan for each setup. After image acquisition, the mask will be removed and stored for treatment. After the simulation, the patients will be asked to fill out a questionnaire evaluating their comfort/anxiety/pain in regards to the setup as a baseline assessment. The patients will be treated with 6 MV from a linear accelerator (Truebeam, Varian Medical Systems, Palo Alto, CA). Dose prescription and treatment planning objectives of the individual patient will be defined by the standard treatment protocol depending on the patient's disease and treatment intention. Before each treatment session, the patient will be positioned on the treatment couch with the designated immobilization material. Conebeam-CT (CBCT) images will be acquired followed by automatic/manual setup correction compared to simulation CT/MRI; a CBCT image will be acquired after the treatment session once a week and at the first three fractions with mask and no mask. The CBCT procedure is a part of the standard treatment protocol for head-and-neck irradiation. Data on CBCT imaging in the form of translational and rotational shifts will be used to measure and compare setup uncertainties (inter-fraction and intra-fraction accuracy) between the two arms. In the no mask arm, Align RT® (Vision RT Ltd., UK) an SGRT system will be used in addition to CBCT imaging, to evaluate translational and rotational motions during treatment and for initial set up and also Gate during treatment. The SGRT system will not be used in patients with immobilization masks on. On the first day of treatment and weekly thereafter (immediately after treatment), the patients will be asked to fill out the same questionnaire as in Simulation for a comfort/anxiety/pain evaluation. As standard practice, patients typically receive another CT simulation during the second half of their treatment, to allow for adjustments to their radiation plan. This is typically due to factors such as weight loss, swelling, tumour or anatomical changes. If necessary, a new mask is also created to account for such changes. This workflow will apply to this study and participants. At the very last treatment session, they will answer the question on their mask or no mask preference.
- Conditions
- Head and Neck Cancers
- Being tested
- Surface guided radiation therapy, Closed face mask
- Keywords
- head and neck cancer, face mask, surface guidance, radiation therapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface guided radiation therapyDevice
Radiation therapy will be delivered using no immobilization mask, but a surface guided system with infrared light
Closed face maskDevice
Radiotherapy with closed face mask for immobilization
| Study group | Role | What they receive |
|---|---|---|
| Closed Mask followed by No Mask | Other | The first half of the treatment is delivered with a face mask, the second half is delivered without mask using surface guidance only Receives: Device: Surface guided radiation therapy; Device: Closed face mask |
| No Mask followed by Closed Mask | Other | The first half of the treatment is delivered without mask using surface guidance only, the second half is delivered with a face mask Receives: Device: Surface guided radiation therapy; Device: Closed face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient discomfort, anxiety and pain
Patients are asked to fill in a short questionnaire to rate their discomfort, anxiety and pain on a visual analogue scale ranging from 0 (=none) to 10 (=extreme)
Measured: weekly from enrollment to end of treatment up to 7 weeks
overall preference
patients are asked to answer the question which treatment modality they preferred (with mask or without mask)
Measured: once at end of treatment (max. 7 weeks)
Secondary outcomes (4)
Setup uncertainties
inter-fraction accuracy is measured with CBCT imaging
Measured: during treatment before every treatment fraction, 5-6 times per week up to 7 weeks
intra-fraction accuracy
intra-fraction accuracy is measured with planar CBCT imaging and an optic surface imaging system
Measured: during treatment before every treatment fraction, 5-6 times per week up to 7 weeks
Serious adverse events
mask-induced and no-mask-induced events will be recorded during treatment
Measured: continuously during treatment up to 7 weeks
Device Deficiencies of the surface guidance system
Device Deficiencies of the surface guidance system are recorded
Measured: continuously during treatment up to 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start12 May 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Panagiotis Balermpas, Prof. Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870799
- Sponsor's protocol ID
- RAO 24-019
- Other IDs
- 2025-D0007
- Acronym
- NoMask
- Status last verified
- Aug 2026
- First submitted
- 24 Feb 2025
- Last updated
- 20 Aug 2026
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy
- ClinicalTrials.gov ID
- NCT06870799
- Acronym / sponsor ID
- NoMask / RAO 24-019
- Conditions
- Head and Neck Cancers
- Keywords
- head and neck cancer, face mask, surface guidance, radiation therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 11 Mar 2025 (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.
At present, open-face masks are used only in patients with claustrophobic anxiety, while all other patients are still immobilized with closed masks, thereby overlooking the need for improvement in patient comfort. Closed face masks in patients undergoing head and neck irradiation have never been compared to no masks in the setting of a randomized clinical trial, but only in feasibility trials. A randomized clinical trial may establish the role of no masks in terms of patient comfort, preference and setup accuracy in all patients.
Detailed description
Once eligibility has been confirmed and upon randomization, patients will begin treatment either with an immobilization mask (A) or no mask (B). One individual immobilization mask and AccuForm cushion will be fabricated for every single patient. All positioning setup information used for subsequent treatment sessions will be documented. One simulation CT/MRI will be acquired and one treatment plan for each setup. After image acquisition, the mask will be removed and stored for treatment. After the simulation, the patients will be asked to fill out a questionnaire evaluating their comfort/anxiety/pain in regards to the setup as a baseline assessment. The patients will be treated with 6 MV from a linear accelerator (Truebeam, Varian Medical Systems, Palo Alto, CA). Dose prescription and treatment planning objectives of the individual patient will be defined by the standard treatment protocol depending on the patient's disease and treatment intention. Before each treatment session, the patient will be positioned on the treatment couch with the designated immobilization material. Conebeam-CT (CBCT) images will be acquired followed by automatic/manual setup correction compared to simulation CT/MRI; a CBCT image will be acquired after the treatment session once a week and at the first three fractions with mask and no mask. The CBCT procedure is a part of the standard treatment protocol for head-and-neck irradiation. Data on CBCT imaging in the form of translational and rotational shifts will be used to measure and compare setup uncertainties (inter-fraction and intra-fraction accuracy) between the two arms. In the no mask arm, Align RT® (Vision RT Ltd., UK) an SGRT system will be used in addition to CBCT imaging, to evaluate translational and rotational motions during treatment and for initial set up and also Gate during treatment. The SGRT system will not be used in patients with immobilization masks on. On the first day of treatment and weekly thereafter (immediately after treatment), the patients will be asked to fill out the same questionnaire as in Simulation for a comfort/anxiety/pain evaluation. As standard practice, patients typically receive another CT simulation during the second half of their treatment, to allow for adjustments to their radiation plan. This is typically due to factors such as weight loss, swelling, tumour or anatomical changes. If necessary, a new mask is also created to account for such changes. This workflow will apply to this study and participants. At the very last treatment session, they will answer the question on their mask or no mask preference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed Mask followed by No Mask | Other | Device: Surface guided radiation therapy, Device: Closed face maskThe first half of the treatment is delivered with a face mask, the second half is delivered without mask using surface guidance only |
| No Mask followed by Closed Mask | Other | Device: Surface guided radiation therapy, Device: Closed face maskThe first half of the treatment is delivered without mask using surface guidance only, the second half is delivered with a face mask |
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 ICH/GCP regulations before any trial specific procedures;
- Indication for head and neck 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 (8 listed)
- Prior head and neck irradiation;
- Women who are pregnant or breast feeding;
- Intention to become pregnant during the course of the trial;
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases;
- Known or suspected non-compliance, drug or alcohol abuse;
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 |
|---|---|---|
| Surface guided radiation therapyRadiation therapy will be delivered using no immobilization mask, but a surface guided system with infrared light | Device | Closed Mask followed by No Mask, No Mask followed by Closed Mask |
| Closed face maskRadiotherapy with closed face mask for immobilization | Device | Closed Mask followed by No Mask, No Mask followed by Closed Mask |
Primary outcome
Patient discomfort, anxiety and pain
Time frame: weekly from enrollment to end of treatment up to 7 weeks
Patients are asked to fill in a short questionnaire to rate their discomfort, anxiety and pain on a visual analogue scale ranging from 0 (=none) to 10 (=extreme)
overall preference
Time frame: once at end of treatment (max. 7 weeks)
patients are asked to answer the question which treatment modality they preferred (with mask or without mask)
4 secondary outcomes
Setup uncertainties
Time frame: during treatment before every treatment fraction, 5-6 times per week up to 7 weeks
intra-fraction accuracy
Time frame: during treatment before every treatment fraction, 5-6 times per week up to 7 weeks
Serious adverse events
Time frame: continuously during treatment up to 7 weeks
Device Deficiencies of the surface guidance system
Time frame: continuously during treatment up to 7 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- 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.
Crystal Sulaiman contact
Panagiotis Balermpas, Prof. Dr. principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surface guided radiation therapy and Closed face mask in people with Head and Neck Cancers, 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 8 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: looking for participants now, as of the sponsor's last update on 20 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katerina Nilo (+41 44 255 35 66, ina.nilo@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient discomfort, anxiety and pain (time frame: weekly from enrollment to end of treatment up to 7 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 20 Aug 2026.