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

Plain Language Summary

Simplified for easier understanding

This study is testing a "prehabilitation" program — a combination of exercise, nutrition support, and other preparatory therapies — started before lung cancer surgery to help patients recover better and reduce complications afterward. The program targets patients who are nutritionally at risk before their surgery. **You may be eligible if...** - You are 45 or older with early to moderately advanced non-small cell lung cancer (Stage I, II, or IIIa) - You are scheduled for lung surgery (video-assisted or open approach) to remove the cancer - You are at nutritional risk based on a standard screening tool (PG-SGA score ≥ 3) **You may NOT be eligible if...** - You have received chemotherapy or radiation in the past 2 months - You are unable to exercise safely (peak exercise capacity below 10 mL O2/kg/min) - You are unable to walk or use a wheelchair - You have an allergy to milk or seafood - You have very high blood calcium levels, very high vitamin D levels, or severe kidney impairment - You do not speak English or French well enough to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.