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Multimodal Prehabilitation for Lung Cancer Surgery

Lung Cancer | Surgery

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    45 and up

Participation Criteria

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.

Study Location

Research Institute of the McGill University Health Centre
Research Institute of the McGill University Health Centre
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Stéphanie Chevalier, PhD

[email protected]
(514) 934-1934
Study Sponsored By
McGill University
Participants Required
More Information
Study ID: NCT05955248