Multimodal Prehabilitation for Lung Cancer Surgery

NCT05955248 | Recruiting

• 1 other identifier: MUHC REB 2022-7782
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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

Keywords

Prehabilitation; Nutritional Supplement

Outcome Measures

Primary Outcomes (2)

• Change in preoperative functional walking capacity

  6-Minute walking test (6MWT): measured as the distance walked during 6 minutes, along a 20-m corridor, expressed in meters

  From baseline (4 weeks pre-surgery) to surgery

• Postoperative functional walking capacity

  6-Minute walking test (6MWT): measured as the distance walked during 6 minutes, along a 20-m corridor, expressed in meters

  6 weeks after surgery

Secondary Outcomes (9)

• Change in handgrip strength

  From baseline (4 weeks pre-surgery) to 6 weeks after surgery

• Change in total skeletal muscle mass

  From baseline (4 weeks pre-surgery) to 6 weeks after surgery

• Change in foreleg muscle surface area

  From baseline (4 weeks pre-surgery) to 6 weeks after surgery

• Change in foreleg myosteatosis (radiodensity)

  From baseline (4 weeks pre-surgery) to 6 weeks after surgery

• Change in body weight and composition

  From baseline (4 weeks pre-surgery) to 6 weeks after surgery

Other Outcomes (16)

• Change in dietary intake

  From baseline (4 weeks pre-surgery) to 6 weeks after surgery

• Change in plasma phospholipid fatty acid profile

  From baseline (4 weeks pre-surgery) to 6 weeks after surgery

• Change in serum vitamin D 25(OH)D concentrations

  From baseline (4 weeks pre-surgery) to 6 weeks after surgery

Study Arms (3)

Control (CTRL)

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo Control (CTRL)

Mixed-nutriend supplement (NUT)

ACTIVE COMPARATOR

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

Dietary Supplement: Mixed-nutriend supplement (NUT)

Multi-modal intervention (MM)

ACTIVE COMPARATOR

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

Dietary Supplement: Mixed-nutriend supplement (NUT); Other: Multimodal Prehabilitation (MM)

Interventions

Mixed-nutriend supplement (NUT) DIETARY_SUPPLEMENT

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).

Mixed-nutriend supplement (NUT); Multi-modal intervention (MM)

Multimodal Prehabilitation (MM) OTHER

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)

Multi-modal intervention (MM)

Placebo Control (CTRL) DIETARY_SUPPLEMENT

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.

Control (CTRL)

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stéphanie Chevalier: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Publications (1)

• Moyen A, Fleurent-Gregoire C, Gillis C, Zaks R, Carli F, Scheede-Bergdahl C, Spicer J, Cools-Lartigue J, Najmeh S, Morais JA, Mazurak V, Chevalier S. Novel multimodal intervention for surgical prehabilitation on functional recovery and muscle characteristics in patients with non-small cell lung cancer: study protocol for a randomised controlled trial (MMP-LUNG). BMJ Open Respir Res. 2025 May 22;12(1):e002884. doi: 10.1136/bmjresp-2024-002884.

  PMID: 40404185 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stéphanie Chevalier, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie Chevalier, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The blinding of exercise is not possible therefore participants will be aware if they are in the MM group. However, research personnel performing outcome assessments will be blinded to group allocation. Groups CTRL and NUT will be double-blinded. Supplements will be packaged by the supplier in coded-labeled sachets (for powder) and bottles (for oil). The supplier will disclose the code to a research person not associated with the trial. Research staff will prepare boxes of supplements (or placebo) according to coded group allocation. All participants will be instructed to not self-supplement with commercially available products, to minimize the risk of group contamination. All data and biological samples will be coded such that participant's identification will not be disclosed to research personnel conducting analyses.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Randomized controlled trial, 3 parallel arms (multimodal intervention, MM; nutritional supplement, NUT; control, CTRL), double-blind and placebo-controlled for supplement, single centre.

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 21, 2023
• Study Start: June 26, 2023
• Primary Completion: September 20, 2025
• Study Completion: March 20, 2026
• Last Updated: July 21, 2023

Record last verified: 2023-07

Locations

CA (1)