Prehabilitation and Early Recovery After Surgery (ERAS) in head and neck cancers: a protocol for a prospective, stratified, open-label randomised controlled trial in adults (PreERA)

Head and neck cancer surgery is associated with substantial physiological stress and functional decline, particularly in patients with compromised nutritional status, reduced exercise capacity and psychological distress. Although Enhanced Recovery After Surgery (ERAS) protocols have improved perioperative outcomes in head and neck oncology, they primarily target intra- and postoperative care and do not adequately address preoperative deficits in functional reserve. Prehabilitation aims to optimise physical, nutritional and psychological health before surgery and may complement ERAS pathways; however, evidence supporting a combined prehabilitation and ERAS approach in head and neck cancer surgery remains limited, especially in non-Western populations. This study is a prospective, stratified, open-label randomised controlled trial conducted at a tertiary cancer centre. Adult patients aged 18–70 years with carcinoma of the buccal mucosa scheduled for elective segmental mandibulectomy will be screened for eligibility and enrolled following informed consent. Participants will be randomised to receive either standard perioperative care or a combined prehabilitation plus ERAS programme, using permuted block randomisation with stratification based on type of reconstruction (free flap or pedicled flap). The intervention group will undergo a minimum of 2 weeks of structured prehabilitation prior to surgery. This will include optimisation of chronic medical conditions, nutritional assessment using Subjective Global Assessment with targeted dietary counselling and supplementation, correction of anaemia, preoperative speech and swallowing therapy, psychological interventions incorporating cognitive behavioural and motivational strategies, and a personalised home-based exercise and respiratory physiotherapy programme. Exercise prescriptions will address jaw mobility, cervical range of motion, shoulder function and aerobic capacity. Both groups will receive perioperative care according to institutional practice, with the intervention arm additionally receiving standardised ERAS components across preoperative, intraoperative and postoperative phases. The primary outcome is postoperative length of hospital stay. Secondary outcomes include major postoperative morbidity, readmissions, functional capacity, speech and swallowing outcomes, biochemical parameters and behavioural changes. All analyses will follow the intention-to-treat principle. This PREERA outlines the rationale and methodology of a multimodal perioperative strategy integrating prehabilitation with ERAS in head and neck cancer surgery. The study aims to inform future perioperative care models and larger definitive trials. Clinical Trials Registry of India (CTRI): CTRI/2026/01/100326. Date of registration: 5 January 2026 (prospectively registered).