A new mask-free system for monitoring patients during radiation therapy for head and neck cancer
Surface Monitoring Technology to Remove The Mask - Stage 1
This study is testing a new device that lets head and neck cancer patients receive radiation therapy without uncomfortable masks to see if it helps them feel more comfortable and relaxed during treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Sydney Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Blacktown, New South Wales) |
| Trial ID | NCT04266223 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates a novel device that allows head and neck cancer patients to undergo radiation therapy without the use of traditional immobilisation masks. Instead, it employs a surface monitoring system that tracks patient movement while they lie on a treatment couch. The study aims to assess patient acceptance of this mask-free approach and evaluate the system's effectiveness in monitoring movement during treatment. By reducing the need for tight-fitting masks, the study seeks to alleviate discomfort and anxiety associated with radiation therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with any stage of head and neck cancer who are receiving radiation therapy with a thermoplastic immobilisation mask.
Not a fit: Patients with cognitive impairments that prevent informed consent or those unable to read and complete questionnaires in English may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient comfort and reduce anxiety during radiation therapy for head and neck cancer.
How similar studies have performed: While traditional immobilisation masks are the clinical standard, the use of mask-free systems is an emerging approach and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * A diagnosis of head and neck cancer, any stage * ≥ 18 years of age * ECOG performance status 0-2 * Receiving radiation therapy for HNC with a thermoplastic immobilisation mask * Any other prior therapy allowed * Willing and able to comply with all study requirements * Must be able to read and complete questionnaires in English Exclusion Criteria * People with cognitive impairment which would preclude them from providing informed consent * People who are unable to speak and read English and for whom obtaining consent would be difficult. Withdrawal Criteria * Participants may withdraw from the study at any time before, during or after participation, and do not have to provide a reason. They may do so by advising any member of the study team, research office or their treating team, by completing the withdrawal of consent form, verbally or in writing. * Participants may be withdrawn from the study by the principal investigator, treating physician or attending clinician if they perceive the participant is experiencing or will likely experience physical or mental harm * No additional study data will be collected for a participant after they withdraw from the study * Withdrawing participants' data will be used unless the participant specifies they no longer give permission for the data to be stored or used, however, their data will not be removed from any analysis or publication that has already occurred, or from study databases once it has been de-identified * Participant will be replaced if they withdraw or are withdrawn from the study prior to starting the second couch session. This will be done by recruitment of an additional participant. * If a couch session is ended by the researcher or participant for reasons unrelated to the study (e.g. not related to equipment failure or participant non-acceptance), the session may be rescheduled, or participant replaced. * Reasons for withdrawal will be reported in any outcome publications.
Where this trial is running
Blacktown, New South Wales
- Blacktown Hospital — Blacktown, New South Wales, Australia (Recruiting)
Study contacts
- Principal investigator: Purmina Sundaresan, Dr — Western Sydney Local Health District
- Study coordinator: Paul Keall, Prof
- Email: paul.keall@sydney.edu.au
- Phone: +61 2 8627 1133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.