Comparing Closed Face Masks vs Surface Guided Radiation Therapy for Head and Neck Radiotherapy (NoMask)

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancers
• Intervention / Treatment: Device: Surface guided radiation therapy; Device: Closed face mask

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 Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katerina Nilo; Phone Number: +41 44 255 35 66; Email: ina.nilo@usz.ch
• Study Contact Backup: Name: Crystal Sulaiman; Email: Crystal.Sulaiman@usz.ch

Study Locations

• Switzerland
  • Zurich, Switzerland, 8091
    • Recruiting
    • University Hospital Zurich
    • Contact: Panagiotis Balermpas, Prof. Dr.; Email: panagiotis.balermpas@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Closed Mask followed by No Mask; The first half of the treatment is delivered with a face mask, the second half is delivered without mask using surface guidance only	Device: Surface guided radiation therapy; Radiation therapy will be delivered using no immobilization mask, but a surface guided system with infrared light; Device: Closed face mask; Radiotherapy with closed face mask for immobilization
Other: No Mask followed by Closed Mask; The first half of the treatment is delivered without mask using surface guidance only, the second half is delivered with a face mask	Device: Surface guided radiation therapy; Radiation therapy will be delivered using no immobilization mask, but a surface guided system with infrared light; Device: Closed face mask; Radiotherapy with closed face mask for immobilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	once at end of treatment (max. 7 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Setup uncertainties	inter-fraction accuracy is measured with CBCT imaging	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	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	continuously during treatment up to 7 weeks
Device Deficiencies of the surface guidance system	Device Deficiencies of the surface guidance system are recorded	continuously during treatment up to 7 weeks

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Panagiotis Balermpas, Prof. Dr., University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: head and neck cancer; radiation therapy; face mask; surface guidance
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: RAO 24-019; 2025-D0007 (Other Identifier: BASEC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No