Radiotherapy for head and neck tumours using an oral fixation and parameter acquisition device and TOMO technology: a randomised controlled study.

Introduction Radiotherapy has become one of the main methods used for the treatment of malignant tumours of the head and neck. Spiral tomographic intensity-modulated radiotherapy has the many advantages of precision radiotherapy, which puts forward high requirements for postural reproducibility and accuracy. We will aim to ensure that the accurate positioning of the tumour will reduce the side effects of radiotherapy caused by positioning errors. We will design and implement this clinical trial using the patent of 'a radiotherapy oral fixation and parameter acquisition device (patent number: ZL201921877986.5)'. Methods and analysis This will be a randomised, controlled, prospective study with 120 patients with head and neck tumours. Using the random number table method, a random number sequence will be generated, and the patients will be enrolled in the experimental group (oral fixation device) and the control group (conventional fixation) in a 2:1 ratio. The primary outcome will be the progression-free survival time after the treatment. Secondary outcomes will include the oral mucosal reaction and the quality of life. Follow-ups will be carried out according to the plan. This is V.1.0 of protocol on 1 April 2021. The recruitment process for this clinical trial commenced on 1 May 2021, and will end on 1 October 2022. Ethics and dissemination The trial received ethical approval from Medical Ethics Committee of Liaoning Provincial Cancer Hospital (number 20210131X). The final results will be presented at a scientific conference and published in a peer-reviewed journal in accordance with the journal's guidelines. Trial registration number ChiCTR2100045096.