Recruiting

Multimodal Prehabilitation

Sponsor:

Stéphanie Chevalier

Code:

NCT05955248

Conditions

Lung Cancer

Surgery

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Mixed-nutriend supplement (NUT)

Multimodal Prehabilitation (MM)

Placebo Control (CTRL)

Study Details

Brief 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.

Conditions

Lung Cancer

Surgery

Study ID

NCT05955248

Start date

Jun 26, 2023

Status verified date

Jul, 2023

Completion date

Mar 20, 2026

Anticipated

Primary completion date

Sep 20, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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 Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

placebo comparator: Control (CTRL)

Participants will be treated following Enhanced Recovery After Surgery (ERAS) protocols + placebo supplements containing maltodextrin and sunflower oil

active comparator: Mixed-nutriend supplement (NUT)

Mixed nutrient supplement containing whey protein, leucine, vitamin D and omega 3 fatty acids

active comparator: Multi-modal intervention (MM)

Multimodal prehabilitation including structured exercise (1 supervised exercise session per week + home-based exercise program), nutritional optimization with dietician, NUT intervention, and relaxation strategies.

Interventions

Mixed-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).

Multimodal 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)

Placebo 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.

Primary outcome measure

  • Change in preoperative functional walking capacity [ Time Frame: From baseline (4 weeks pre-surgery) to surgery ]
  • Postoperative functional walking capacity [ Time Frame: 6 weeks after surgery ]

Central Contacts and Locations

Central contacts

Stéphanie Chevalier, PhD

(514) 934-1934stephanie.chevalier@mcgill.ca

Locations

Research Institute of the McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Stéphanie Chevalier, PhD

(514) 934-1934stephanie.chevalier@mcgill.ca

More Information

Sponsor

Stéphanie Chevalier

Last update posted

Jul 21, 2023

Last verified

Jul, 2023

Keywords

  • Prehabilitation
  • Nutritional Supplement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stéphanie Chevalier on 2023-07-21.