Multidisciplinary Rehabilitation Following Upper Gastrointestinal Cancer Surgery (RESTORE II): A Definitive Randomized Controlled Trial.

OBJECTIVE: RESTORE II compared in an RCT the impact of a 12-week multidisciplinary rehabilitation program versus standard care (SC) on cardiorespiratory fitness and physical function in patients postupper gastrointestinal (UGI) oncologic surgery. SUMMARY OF BACKGROUND DATA: The value of multidisciplinary cancer rehabilitation in UGI cancer survivorship is unclear, with limited high-quality data. METHODS: Disease-free patients, ≥3 months post-UGI cancer resection were randomized to SC or RESTORE (physiotherapy-led aerobic and resistance exercise, dietary counselling, and psychosocial support). The primary endpoint was cardiorespiratory fitness (VO2peak). Secondary endpoints included body composition (anthropometry and bioimpedance analysis), muscle strength (hand grip strength and leg-press 1-repetition maximum), functional performance (Short Physical Performance Battery), physical activity (accelerometery), and health-related quality of life (EORTC-QLQ-C30). Assessments were conducted at baseline (T0), postintervention (T1), and 3-month follow-up (T2). RESULTS: Eighty-eight participants were randomized to SC (n=44) or RESTORE (n=44). Median age was 67.5 (range: 43-86) years, n=60 (68.2%) male, and median time postsurgery was 33 (range: 3.5-145) months. VO₂peak remained stable in the SC group. Estimated interaction effects for time×group indicate that the mean increases in VO₂peak were greater for RESTORE relative to SC from baseline to T1, by a mean of 1.5 mL/min/kg (95% CI: 0.52-2.48; P-value=0.003), and from baseline to T2 by a mean of 1.23 mL/min/kg (95% CI: 0.18-2.27; P-value=0.02). Secondary endpoints remained stable across treatment arms with no significant differences observed. CONCLUSION: RESTORE II provides Level I evidence that cardiorespiratory fitness can be targeted and improved in survivors of UGI cancer surgery.