Multimodal Prehabilitation for Lung Cancer Surgery
NCT05955248
Summary
The main objective of this randomized controlled trial (RCT) is to investigate whether a multimodal prehabilitation intervention combining a mixed-nutrient supplement with structured exercise training (MM) or the supplement alone (NUT), against a placebo (CTRL), leads to improvement in functional capacity and postoperative outcomes in surgical patients with lung cancer, at nutritional risk. This will be tested in a single centre RCT of 3 parallel arms, double-blinded for the supplement. Female and male participants (n=168, \>=45 y) will be randomized to a 10-week intervention spanning 4 weeks pre-surgery and 6 weeks post-hospital discharge. The primary outcome is functional capacity as measured by the 6-minute walk test. Secondary outcomes include muscle mass, quality and strength, quality of life, length of hospital stay, and postoperative complications.
Eligibility
Inclusion Criteria: * Adults aged 45 years and over * Diagnosed with NSCLC stages I, II or IIIa and scheduled for video-assisted thoracic surgery (VATS) or open thoracotomy surgery for cancer resection * At nutritional risk (defined as Patient Generated-Subjective Global Assessment score = or \>3) Exclusion Criteria: * Prior recent (\<2 months) adjuvant therapy (chemo- or radio-therapy) * Inability to perform, or comorbidities contraindicating, exercise (defined as CPET \<10 mL O2/kg/min) * Unable to walk (uses a wheelchair) * Allergy to milk or seafood * Hypercalcemia (total serum Ca \>2.60 mmol/L or ionized Ca \>1.30 mmol/L) * Hypervitaminosis D (serum 25(OH)D \>375 nmol/L) * Glomerular filtration rate (\<30 mL/min/1.73m2) * Insufficient understanding of English or French to provide informed consent Patients taking omega-3 FA supplements will be asked to withhold them during the study; those taking vitamin D will continue unless baseline serum 25(OH)D \>80 nmol/L.
Conditions3
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NCT05955248