Normalcy of Swallowing in Head and Neck Cancer Patients Undergoing Particle Therapy Supported by Combined Swallowing Training and Feeding Management: A Randomised Controlled Trial

ABSTRACT Objective As a common complication following particle therapy for head and neck cancer (HNC), dysphagia poses significant risks and adverse outcomes for patients. This study aims to investigate the efficacy of an evidence‐based combined regimen of feeding management and swallowing training on improving swallowing function, swallowing‐related quality of life and nutritional status in patients with dysphagia. Methods We conducted a randomised parallel‐controlled trial at the Shanghai Proton and Heavy Ion Center from March 2023 to October 2023. The study included patients aged 18 or older with HNCs undergoing particle therapy, with or without concurrent chemotherapy. Patients with dysphagia caused by conditions other than cancer were excluded. Patients were randomly assigned to intervention or control groups. The control group received routine radiotherapy care during and 3 months post‐treatment, while the intervention group received an additional combined regimen of feeding management and swallowing training. The control group received standard radiotherapy care during treatment and for 3 months post‐treatment. In addition, the intervention group was instructed to undergo preventive swallowing training at the start of treatment, with feeding management measures (adjusting food texture, bite size, eating speed, posture and utensils) implemented once swallowing discomfort occurred. Swallowing function was assessed using the Eating Assessment Tool‐10 (EAT‐10). Swallowing‐related quality of life was measured with the M.D. Anderson Dysphagia Inventory (MDADI), which covers emotional, functional, physical and global dimensions. Nutritional status was evaluated based on Body Mass Index (BMI) and the Nutrition Risk Screening 2002 (NRS2002). Assessments were performed at baseline, immediately post‐treatment (within 3 days after completion of treatment) and 3 months post‐treatment. Results Ninety‐six patients were enrolled in this study, with 48 in the intervention group and 48 in the control group. Group effect analysis revealed that the intervention group outperformed the control group in improving swallowing function ( p = 0.002) and overall swallowing‐related quality of life ( p = 0.001). Time effects also indicated improvements in swallowing function and quality of life in the intervention group compared to baseline ( p < 0.001), with no significant interaction effect ( p > 0.05). Specifically, improvements were observed in the functional dimension ( p < 0.001) and physical dimension ( p < 0.001) of swallowing‐related quality of life in the intervention group. The MDADI total scores showed a clinically significant difference (> 10 points) between groups. However, no significant between‐group differences were found in BMI values ( p = 0.474) or NRS2002 scores ( p = 0.957). Conclusion Our study indicates that combining feeding management and swallowing training effectively enhances swallowing function and quality of life in HNC patients receiving particle therapy. However, insufficient evidence was found to support its impact on nutritional status or malnutrition risk. Trial Registration ClinicalTrials.gov identifier: ChiCTR2300067550