Trial Protocol: OPEN: Optimising Patient Experience in head and Neck radiotherapy, A phase 3 randomised control trial comparing open versus closed face masks for patients undergoing head and neck radiotherapy.

Jill nicholson; Samantha Ryan; Ciaran Malone; roisin o'maolalai; Orla McArdle; Fances K Dunne; lorna keenan; john armstrong; aisling glynn; Bahareh Khosravi; Ruth woods; Brendan McLean; william garrett; rachel harwood; michelle leech; sara faithful; Victoria Lunt; Sinead Brennan

doi:10.12688/hrbopenres.14112.1

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Study Protocol

Trial Protocol: OPEN: Optimising Patient Experience in head and Neck radiotherapy, A phase 3 randomised control trial comparing open versus closed face masks for patients undergoing head and neck radiotherapy.

[version 1; peer review: awaiting peer review]

Jill nicholson ^1,2, Samantha Ryan¹, Ciaran Malone¹, [...] roisin o'maolalai¹, Orla McArdle^1,3, Fances K Dunne^1,2, lorna keenan^1,3, john armstrong¹, aisling glynn^1,3, Bahareh Khosravi¹, Ruth woods¹, Brendan McLean¹, william garrett¹, rachel harwood¹, michelle leech², sara faithful², Victoria Lunt³, Sinead Brennan^1,2

Jill nicholson ^1,2, Samantha Ryan¹, [...] Ciaran Malone¹, roisin o'maolalai¹, Orla McArdle^1,3, Fances K Dunne^1,2, lorna keenan^1,3, john armstrong¹, aisling glynn^1,3, Bahareh Khosravi¹, Ruth woods¹, Brendan McLean¹, william garrett¹, rachel harwood¹, michelle leech², sara faithful², Victoria Lunt³, Sinead Brennan^1,2

PUBLISHED 12 May 2025

Author details Author details

¹ St Luke's Hospital, St Luke's Radiation Oncology Network, Rathgar, Dublin 6, Ireland
² Discipline of Radiation Therapy &Trinity St James’s Cancer Institute,, Applied Radiation Therapy Trinity, Trinity College Dublin,, Dublin, Ireland
³ Royal College of Surgeons, Beaumont Cancer Institute, Dublin, Ireland

Jill nicholson
Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Validation, Writing – Original Draft Preparation, Writing – Review & Editing

Samantha Ryan
Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Writing – Review & Editing

Ciaran Malone
Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Writing – Review & Editing

roisin o'maolalai
Roles: Conceptualization, Data Curation, Investigation, Methodology, Project Administration, Writing – Review & Editing

Orla McArdle
Roles: Conceptualization, Methodology, Resources, Supervision, Validation, Writing – Review & Editing

Fances K Dunne
Roles: Conceptualization, Methodology, Resources, Supervision, Validation, Writing – Review & Editing

lorna keenan
Roles: Conceptualization, Methodology, Supervision, Validation, Writing – Review & Editing

john armstrong
Roles: Conceptualization, Methodology, Supervision, Validation, Writing – Review & Editing

aisling glynn
Roles: Conceptualization, Investigation, Methodology, Validation, Writing – Review & Editing

Bahareh Khosravi
Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Project Administration, Writing – Review & Editing

Ruth woods
Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Supervision, Writing – Review & Editing

Brendan McLean
Roles: Conceptualization, Investigation, Methodology, Supervision, Writing – Review & Editing

william garrett
Roles: Conceptualization, Investigation, Methodology, Project Administration, Writing – Review & Editing

rachel harwood
Roles: Conceptualization, Investigation, Methodology, Project Administration, Writing – Review & Editing

michelle leech
Roles: Data Curation, Formal Analysis, Software, Supervision, Writing – Review & Editing

sara faithful
Roles: Data Curation, Formal Analysis, Investigation, Methodology, Supervision, Writing – Review & Editing

Victoria Lunt
Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Writing – Review & Editing

Sinead Brennan
Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS AWAITING PEER REVIEW

Abstract

Background

Current radiotherapy treatment techniques for head and neck cancer use closed thermoplastic masks to ensure accurate and effective immobilization. Patients often tolerate these masks poorly, and many experience symptoms of claustrophobia and distress. This prospective randomized controlled Phase III trial has been developed to compare the setup accuracy and patient experience between three types of masks for head and neck cancer patients: standard closed 5 points, open 5 points, and open 3 point radiotherapy masks.

Methods

The study will be conducted across a 3 site radiotherapy network, including 201 patients. Patients will be randomised into three arms on a 1:1:1 basis. The inclusion criteria will be all patients undergoing radical radiotherapy of 30-35 fraction duration for head and neck cancer. To ensure daily set up accuracy and patient safety, patients on all three arms will be imaged daily with cone beam CT (CBCT). Surface-guided technology will be used for open arms measuring both inter- and intrafraction motion. Patient distress and experience with masks will be evaluated through a GHQ 12 questionnaire and questions on their perceptions.

Discussion

Studies have demonstrated the safety of open masks when combined with surface-guided technology to maintain adequate setup accuracy for treatment delivery. The reduced surface in contact with the patient requires robust evaluation to ensure effective immobilization. An earlier study in claustrophobic patients was conducted; however, open masks were not evaluated in a large randomized trial for patients without claustrophobia. The overall purpose of the trial was to evaluate whether open face masks in conjunction with modern treatment verification technology should be the new standard of care, providing safe and effective immobilization and better treatment experience for all patients undergoing head and neck radiotherapy.

Trial Registration

CTI 23-24, Caner Trials Ireland January 24 https://www.cancertrials.ie/cti-trials/open/ NCT06327139 January 2024 https://clinicaltrials.gov/ct2/show/NCT06327139/

Keywords

Head and neck Cancer, Radiotherapy Mask, Faceless, Surface guided Radiotherapy

Corresponding author: Jill nicholson

Competing interests: Masks were provided free of charge from Orfit Industries for the purpose of this trial. They were approached by the research team, following a pilot review of the various commercial options available. They were not involved in study conception, design or analysis.

Grant information: Health Research Board CTIC-2021-007
This work is also supported by Cancer Research Fund, via St Luke’s Institute of Cancer Research, Dublin, Ireland (SLICR 2023/7542).

The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2025 nicholson J et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: nicholson J, Ryan S, Malone C et al. Trial Protocol: OPEN: Optimising Patient Experience in head and Neck radiotherapy, A phase 3 randomised control trial comparing open versus closed face masks for patients undergoing head and neck radiotherapy. [version 1; peer review: awaiting peer review]. HRB Open Res 2025, 8:60 (https://doi.org/10.12688/hrbopenres.14112.1) First published: 12 May 2025, 8:60 (https://doi.org/10.12688/hrbopenres.14112.1) Latest published: 12 May 2025, 8:60 (https://doi.org/10.12688/hrbopenres.14112.1)

Introduction

Radiotherapy plays a key role in the treatment of head and neck cancer, both as a definitive treatment and in conjunction with chemotherapy and surgery, with >60% of patients receiving radiotherapy at some point in the cancer treatment journey¹. Advances in radiotherapy technologies have led to improved outcomes, significantly improving both local control and quality of life^2–4. Achieving these benefits requires accurate immobilization to ensure safe and precise delivery of treatment, thereby minimizing radiation exposure to critical structures and reducing side effects. Current radiotherapy treatment techniques for head and neck cancer use a full-face closed thermoplastic mask to ensure accurate and effective immobilization⁵.

Previous studies have reviewed open masks; however, to date, there have been no large randomized trials assessing their accuracy and potential benefits to patient experience^6–8. Wiant et al. reported a prospective evaluation of open versus closed masks and demonstrated comparable immobilization and a non-significant reduction in anxiety scores across 50 patients with head and neck pain⁷. Mulla et al. demonstrated that closed masks were comparable in terms of accuracy to open masks for head and neck radiotherapy across 40 patients, but they only assessed using cone beam CT (CBCT) and did not use surface-guided technology to assess or improve the accuracy⁶. Lee et al. presented preliminary data for five claustrophobic patients and demonstrated the acceptability of reinforced open masks⁸.

To achieve the necessary precision for radical radiotherapy, a comprehensive understanding of the patient's anatomy and its potential movements during treatment is crucial. The two key terminologies that describe the types of motion that occur are inter-fraction and intrafraction motion⁹. Both types of motions have a profound influence on treatment margins. Larger margins increase the irradiated volume, potentially leading to higher toxicity and side effects. However, inadequate margins may lead to tumor recurrence due to the under-dosage of regions within the tumor^10,11.

Traditional closed radiotherapy masks have been described as one of the most challenging aspects for patients undergoing radical head and neck radiotherapy¹². Patients must tolerate a mask daily for 6–7 weeks of treatment, considering the changing contours and increasing side effects as the treatment progresses. Difficulty tolerating masks can lead to interruptions in treatment, which is detrimental to overall outcomes, prolongs setup time, and reduces linear accelerator efficiency¹³. Anxiety associated with traditional masks has been reported in over 26% of patients undergoing head and neck radiotherapy^14,15. Patient distress levels during radiotherapy have been reported to be prognostic factors for overall survival¹⁶. In a recent meta-analysis of mental well-being in patients with head and neck cancer 34.3% reported psychological distress but on clinical diagnostic criteria 10% had depression and 5.6% anxiety disorders¹⁷. Therefore, effective interventions to overcome or reduce anxiety while maintaining the required immobilization accuracy are desirable.

This trial's rationale stems from the need to enhance patient experience during head and neck radiotherapy without compromising the accurate delivery of treatment, and we hypothesized that open masks could maintain position accuracy while improving patient experience. This prospective randomized controlled Phase III trial was developed to compare the setup accuracy and patient experience between conventional closed face masks and two types of open-face masks in radiotherapy for patients with head and neck cancer.

Methods

Trial Registered - CTI 23-24, Caner Trials Ireland January 24 https://www.cancertrials.ie/cti-trials/open/ NCT06327139 January 2024 https://clinicaltrials.gov/ct2/show/NCT06327139

This was a comparative, non-blinded, three-arm, randomized clinical trial. This study will be conducted across three radiotherapy centres for 12-18months. The primary objective was to compare the setup accuracies of the three types of masks. Our secondary objectives were to: 1) examine patients' distress levels at two distinct points during their treatment, 2) assess the utility and advantages of surface-guided radiotherapy (SGRT) for monitoring intrafraction motion in comparison to cone Beam CT imaging techniques, and 3) evaluate differences in treatment setup times and resource utilization across the three study groups within the treatment unit. The three intervention arms included a conventional 5-point closed radiotherapy mask, 5-point open radiotherapy mask and a 3-point open radiotherapy mask (with shoulder retractors) (Figure 1).

Figure 1. Trial Schema for open trial.

This trial strives to follow a green ethos format, and has been designed to be fully electronic with no paper records and to use biodegradable and recyclable masks.

Participants

This study aimed to recruit 201 patients with head and neck cancer who underwent radical radiotherapy, randomized equally across the three trial arms. All patients will receive standard care in terms of target volume, delineation, prescription and treatment planning, and standard image-guided Radiation Therapy (IGRT) protocol.

Inclusion Criteria;

1) All patients undergoing 30–35 fractions of radical head and neck cancer radiotherapy

2) Written informed consent obtained prior to any study-specific procedures in accordance with ICHGCP

3) ≥18 years of age

4) Patients may receive chemotherapy as per local institutional practice.

Exclusion Criteria

1) Patients who would not tolerate or would be unable to proceed with treatment if placed in a standard closed mask at the discretion of either the patient or clinician.

Enrolment, consent and randomisation

Potential patients were screened and enrolled in the study based on the eligibility criteria specified above. Only patients fulfilling all the inclusion criteria and none of the exclusion criteria were eligible for study registration.

After the study was fully explained, written informed consent was obtained from the patient before study participation (Appendix B). The method of obtaining and documenting informed consent and the contents of the consent will comply with the ICH-GCP and all the applicable requirements. All participants will have adequate time to process the information given and to ask questions in line with the good clinical practice (GCP). Investigators will document the obtaining of informed consent, including the date of each patient’s medical record. To maintain patient privacy, all (e)CRFs, study reports, and communications will identify the patient by the assigned patient number only.

Randomization will be performed during patient registration. A random number generator generates a number between 1 and 3 for each patient. Treatment allocation was 1:1:1 for each arm.

Setup accuracy and motion verification

The setup accuracy was assessed through inter-fraction and intrafraction variation measurements. Interfraction variation was assessed using CBCT setup data across each treatment arm. The difference in position between the treatment (CBCT) and reference (CT) scans will be recorded for each fraction, providing both translational and rotational setup error data as a part of our primary outcome. Intrafraction variation will be assessed through pre- and intra-arc CBCT imaging, as well as surface-guided radiotherapy (SGRT) monitoring. The comparison of pre- and intra-treatment arc motion with that measured using SGRT allowed a comprehensive evaluation of intrafraction movement using two independent measurement approaches. The setup time was assessed using SGRT-recorded timings. Data related to the number of replans in each arm were also recorded.

Psychological distress

The GHQ-12 questionnaire will be administered by the research team to participants with the aim of assessing and comparing patients’ mental well-being and distress levels between the three groups. These assessments will be completed at two time points throughout the course of treatment during the first and last weeks of treatment (Table 1). This approach aims to capture patients’ mental well-being across the duration of their treatment course and to compare the level of distress between open and closed masks. Psychological support was routinely available for all patients. Those who engage in psychological support are noted as a subgroup of interest. Patients will also be asked four additional questions to rate their comfort and tolerance of the treatment mask at both time points (Appendix A).

Table 1. Table of assessments for patients participating in open trial.

	Pre-Registration / Randomisation (Baseline)	AT CT Simulation	Radiotherapy Study Treatment				Treatment Completion
	Pre-Registration / Randomisation (Baseline)	AT CT Simulation	Daily throughout RT	Weekly throughout RT	First week of RT	Last week of RT	Treatment Completion
Informed consent	x
Eligibility Criteria, demographics	x
Medical History	x
Disease/tumour characteristics (Histopathology, diagnosis grade, stage, etc.)	x
ECOG-PS	x
Height, Weight, BMI	x
Screen for benzodiazepine use	x
CT Simulation (if applicable)		x
Anxiety Questionnaire					x	x
Daily CBCT			x
Set up moves recorded			x
Treatment Time recorded			x
Adverse event evaluation Treatment cessation, mask stretch or cutting, replan, (Toxicity Assessment)*							x
End of study form							x

Radiomics sub study

Patients are also invited to enrol in a radiomics sub-study that aims to evaluate the efficacy of radiomics/machine learning approaches in predicting anatomical changes, necessitating replanning and redesigning of the patient’s radiotherapy plan. All patients will be offered the opportunity to enrol in the study.

Data collection and management

The data will be recorded on the electronic CRFs. All data related to patient setup, monitoring, and intrafraction motion will be downloaded in CSV format from the Align RT surface-guided software and ARIA for analysis. Each CSV file was parsed using an in-house Python script to extract intrafraction motion data. Anxiety evaluation forms were recorded electronically on the QATrack. Data will be extracted in the CSV format for analysis. All data collection processes strictly adhered to the approved trial CRF, questionnaire, and measured intra- and inter-fraction setup data outlined in this protocol.

Sample size

The sample size of 201 patients was justified based on power calculations to detect clinically significant differences in setup accuracy and patient experience across the three arms. It was adjusted in terms of the population sample size considerations.

Statistical analysis

This prospective randomized Phase III design was chosen to ensure the most robust comparison of the three different types of masks in terms of setup accuracy and patient experience. Statistical analysis primarily follows a frequentist methodology. Additionally, we employed Bayesian analysis to complement this by enabling the extraction of clinically significant insights from the observed differences in the setup. The analysis will encompass both primary and secondary endpoints, as defined above, and will be conducted using various techniques, including a one – way ANOVA, paired t-tests, a generalized estimating equations model, and Bayesian differences of means. The results for the GHQ questionnaire were coded and analyzed using non-parametric statistics. We will use a significance level of 0.05 for all statistical tests. Data analysis was conducted using the R and Stata software. Stratification factors were not identified. Any deviations from the original statistical plan will be reported in the study results along with the rationale for such deviations.

Trial monitoring

There will be a trial oversight steering committee consisting of co-investigators who meet regularly and monitor the progress of the trial. The chief investigator and co-investigators will review the pre- and post cone beam images for the first 50 patients and assess the intrafraction motion for the two faceless mask cohorts. If there is evidence of insufficient mobilization in either arm, treatment in that arm will cease, and a full review of the clinical trial will be conducted. The patients will continue treatment but may need to be moved to an alternative arm. The SAE(s) will also be reported to the concerned Ethics Committee; this is the responsibility of the site.

Ethics and dissemination

Ethical Approval was granted by the St Luke’s Radiation Oncology Network Research Ethics Committee in September 2023. The study will be conducted in accordance with ethical principles founded in the Declaration of Helsinki (current edition located at: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/).

The ethics committee in SLRON will review all appropriate study documentation in order to safeguard the rights, safety and well-being of the patients.

The investigator will conduct the study in compliance with the current approved protocol/protocol amendment and in compliance with ICH-GCP and applicable requirements and to ensure that all persons assisting with the study are adequately informed about the study treatment(s) and their study-related duties and functions.

The findings will be disseminated through publication in peer-reviewed journals and through relevant national and international conferences.

Consent to participate

After the study is fully explained, written informed consent will be obtained from the patient before study participation (Appendix B). The method of obtaining and documenting informed consent and the contents of the consent will comply with the ICH-GCP and all the applicable requirements. Consent will be obtained by clinical trial staff including radiation therapists and doctors listed on documentation. All participants will have adequate time to process the information given and to ask questions in line with the GCP. Investigators will document the obtaining of informed consent, including the date of each patient’s medical record.

Discussion

An earlier study was carried out at our institution by Glynn et al.¹⁸, which included only 30 patients treated with a 5-point open mask due to underlying anxiety. They demonstrated that open masks can maintain setup accuracy at levels comparable to those of closed masks and may be offered to patients with mask anxiety. This demonstrated the feasibility of such an approach and suggested that a larger randomized study should be performed to investigate faceless masks as a potential new standard of care for all patients undergoing radiotherapy in the head and neck region. They also proposed the use of SGRT to further improve the accuracy of the setup and intrafraction motion monitoring with faceless masks. Additionally, a feasibility study was undertaken using SGRT with both three- and 5-point open facemasks and trialling several vendors. This study was conducted to refine the SGRT surfaces used for both setup and treatment monitoring, to design our institutional protocol, and to confirm which immobilization devices and mask manufacturers would be used for the trial.

Traditional radiotherapy masks can cause distress owing to claustrophobia, anxiety, and discomfort in a significant number of patients¹². The proposed faceless open masks aimed to alleviate these negative feelings and enhance patient comfort and experience. However, a reduced surface in contact with the patient requires robust evaluation to ensure effective immobilization for accurate treatment. The overall purpose of the trial was to determine whether open face masks should be the new standard of care, providing safe and effective immobilization, and a better treatment experience for all patients undergoing head and neck radiotherapy. The trial will recommend open masks as a new standard of care if either of the two open masks has superior or equivalent setup accuracy compared to the closed mask and provides patients with a meaningful difference in tolerability.

List of abbreviations

If abbreviations are used in the text, they should be defined in the text at first use and a list of abbreviations should be provided.

H&N: Head and Neck

SLRON: St. Luke's Radiation Oncology Network

CBCT: Cone Beam Computed Tomography

SGRT: Surface Guided Radiotherapy

Data availability

No data associated with this article.

Extended data

Figshare : Trial Protocol: OPEN: Optimising Patient Experience in head and Neck radiotherapy, A phase 3 randomised control trial comparing open versus closed face masks for patients undergoing head and neck radiotherapy. https://doi.org/10.6084/m9.figshare.28640069.v1

The above DOI contains Appendixes for this article¹⁹.

Reporting guidelines

Figshare : Spirit Checklist “Trial Protocol: OPEN: Optimising Patient Experience in head and Neck radiotherapy, A phase 3 randomised control trial comparing open versus closed face masks for patients undergoing head and neck radiotherapy”. DOI : https://doi.org/10.6084/m9.figshare.28640066.v1²⁰

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0)(https://creativecommons.org/licenses/by/4.0/).

Acknowledgements

Not applicable

Faculty Opinions recommended

References

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