- Design
- Phase 3, three-arm randomised trial
- Population
- 230 non-claustrophobic adults having radical head and neck radiotherapy
- Primary outcome
- Set-up accuracy on daily cone-beam CT
- Effect
- No difference except longitudinal axis, where closed masks shifted more (P below 0.001)
A phase 3 trial randomised 230 non-claustrophobic patients having radical head and neck radiotherapy to a standard closed five-point mask, or to open three-point or open five-point masks supported by surface-guided radiotherapy (SGRT), which tracks the face during treatment.
Daily cone-beam CT showed the closed mask had larger shifts along the head-to-foot axis; other axes did not differ. At the end of treatment, both open-mask groups reported better tolerability, overall experience and lower distress than the closed-mask group.
Closed thermoplastic masks are one of the most distressing parts of head and neck radiotherapy. This trial suggests that, where surface guidance is available, an open mask can be used without losing set-up accuracy.
The trial excluded claustrophobic patients, who might benefit most, and surface-guidance equipment is not available in many Indian centres.
- Ask patients about mask distress during radiotherapy, not only at the start.
- Where surface guidance is available, open masks are an option for suitable patients.
- Set-up accuracy was not worse with open masks in this trial.
- Claustrophobic patients were excluded, so evidence for them is lacking.
Why it matters
Mask distress may be an avoidable part of treatment rather than a necessary one.
The statistics, in plain English
The trial reports significance tests rather than effect sizes in the abstract, so the size of the patient-experience benefit is not given here.
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