RecruitingNot ApplicableNCT05955248

Multimodal Prehabilitation for Lung Cancer Surgery

A Novel Multimodal Intervention for Surgical Prehabilitation of Patients With Lung Cancer: the MMP-LUNG Trial

Sponsor

Stéphanie Chevalier

Enrollment

168 participants

Start Date

Jun 26, 2023

Study Type

INTERVENTIONAL

Conditions

Surgery Lung Cancer

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

Min Age: 45 Years

Inclusion Criteria3

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 Criteria9

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.

Interventions

DIETARY_SUPPLEMENTMixed-nutriend supplement (NUT)

Participants will follow ERAS protocol and will receive dietary counselling and anxiety management counselling as needed. They will receive the active multi-nutrient supplement made of whey protein + leucine + vitamin D doses pre-mixed in unlabeled packets prepared by Gruppo Nutrition to dilute in a cup (250 mL) of water. In addition, participants will ingest 15 mL of fruit-flavored fish oil, provided as a liquid oil. They will receive a dosing cup, pre-marked to 15 mL, for a total dose providing 2120 mg eicosapentaenoic acid (EPA) and 1320 mg docosahexaenoic acid (DHA).

OTHERMultimodal Prehabilitation (MM)

Participants will follow ERAS protocol and will receive dietary counselling and anxiety management counselling as needed. They will receive the NUT intervention + structured exercise training prescribed by a kinesiologist (1. 30 min of aerobic exercise per day of their preferred type (ex. walking) and 2. 30 min of resistance exercise targeting major muscle groups, every second day for 2 sets of 8-12 reps). Training will be performed for 4 weeks prior to surgery (1x/week supervised by kinesiologist at hospital, 2x/week at alone at home)

DIETARY_SUPPLEMENTPlacebo Control (CTRL)

Participants will follow ERAS protocol and will receive dietary counselling and anxiety management counselling as needed. They will receive a placebo dietary supplement made of maltodextrin and sunflower oil.