Effectiveness of an evidence-based swallowing facilitation strategy for patients undergoing radiotherapy for head and neck cancer: a study protocol for a randomised controlled trial

Abstract

Introduction: Dysphagia emerges as a frequent, persistent and enduring aftermath in individuals undergoing radiotherapy for head and neck cancer (HNC). Timely intervention becomes imperative to ameliorate prolonged dysphagia and curtail related complications. Among the evidence-grounded tactics, preventive swallowing training and proficient feeding management stand out as pivotal measures for precluding and mitigating dysphagia. However, past inquiries that amalgamated these dual interventions exhibited heterogeneous quality due to their restricted participant cohorts and a dearth of uniform, systematic and practicable procedural benchmarks.

Method/design: This randomised, parallel-controlled study enrols 94 patients diagnosed with HNC, who are undergoing radiotherapy either with or without concurrent chemotherapy. The patients will be randomly assigned to either the intervention group, which will receive a facilitation strategy to enhance swallowing function in conjunction with standard care, or the control group, which will receive typical radiotherapy care. Patient assessments will be conducted at three distinct time points: at the onset of radiotherapy (baseline), at the conclusion of radiotherapy and 3 months postradiotherapy. The primary outcome will revolve around measuring swallowing function, while secondary outcomes will encompass swallowing-related quality of life and nutritional status.

Ethics and dissemination: This research initiative received endorsement from the Shanghai Proton Heavy Ion Hospital Ethics Committee on 2 December 2 (Approval Number 2210-59-01). Throughout the recruitment process, patients will be acquainted with the primary aims and scope of the study. Their participation will be a voluntary choice, demonstrated by their informed consent form signatures. The outcomes of this study will be disseminated through publication in a peer-reviewed journal.

Trial registration number: Clinical Trials.gov, ChiCTR2300067550, registered 11 January 2023.

Keywords: Head & neck tumours; Protocols & guidelines; RADIOTHERAPY.