Design and evaluation of the pulmonary rehabilitation programme for patients with oral and maxillofacial cancer: a randomised controlled trial protocol.

Abstract

Introduction: Postoperative pulmonary complications are a common and significant concern following head and neck surgeries. Patients with oral and maxillofacial cancer are particularly susceptible to reduced pulmonary function, impaired exercise capacity and diminished quality of life. Pulmonary rehabilitation (PR) has been widely validated as an effective intervention for managing respiratory diseases, improving functional capacity and enhancing health-related quality of life. However, a critical gap persists in developing PR programmes specifically tailored to the distinct physiological and functional challenges faced by patients with oral and maxillofacial cancer. This protocol introduces an innovative PR intervention uniquely designed to address these challenges, bridging the gap in current rehabilitation practices and offering a comprehensive approach to improve recovery outcomes.

Methods and analysis: This single-blind, two-arm, randomised controlled trial will enrol 144 patients with oral and maxillofacial malignancies from a tertiary hospital in China. Participants will be randomly assigned to either the intervention group (n=72), receiving routine care alongside a tailored PR programme designed by the research team, or the control group (n=72), receiving routine care alone. The primary outcome is pulmonary function, which is assessed using pulmonary function tests. Secondary outcomes include exercise capacity, quality of life and cancer-related fatigue. Outcomes will be assessed at three time points: baseline (T0), before discharge and 2 months postdischarge (T1), allowing for evaluation of both immediate and sustained intervention effects.

Ethics and dissemination: The trial has received ethical approval from the Ethics Committee of West China Hospital of Stomatology, Sichuan University (WCHSIRB-D-2025-025). Study findings will be disseminated through peer-reviewed journals and conference presentations.

Trial registration number: ChiCTR2500099236.