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

Status: Recruiting
Location: See location...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Canada
Research Institute of the McGill University Health Centre
RECRUITING
Montreal
Contact Information
Primary
Stéphanie Chevalier, PhD
stephanie.chevalier@mcgill.ca
(514) 934-1934
Time Frame
Start Date: 2023-06-26
Estimated Completion Date: 2026-03-20
Participants
Target number of participants: 168
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: Stéphanie Chevalier

This content was sourced from clinicaltrials.gov