Trial Title:
Multimodal Prehabilitation for Lung Cancer Surgery
NCT ID:
NCT05955248
Condition:
Lung Cancer
Surgery
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Prehabilitation
Nutritional Supplement
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized controlled trial, 3 parallel arms (multimodal intervention, MM; nutritional
supplement, NUT; control, CTRL), double-blind and placebo-controlled for supplement,
single centre.
Primary purpose:
Supportive Care
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
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.
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Mixed-nutriend supplement (NUT)
Description:
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).
Arm group label:
Mixed-nutriend supplement (NUT)
Arm group label:
Multi-modal intervention (MM)
Intervention type:
Other
Intervention name:
Multimodal Prehabilitation (MM)
Description:
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)
Arm group label:
Multi-modal intervention (MM)
Intervention type:
Dietary Supplement
Intervention name:
Placebo Control (CTRL)
Description:
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.
Arm group label:
Control (CTRL)
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.
Detailed description:
RATIONALE: The preoperative period is an opportune time to actively engage and empower
patients in improving their functional, nutritional and mental status in anticipation of
the surgical stress. Considering that lung cancer patients often present with poor
nutritional status and physical function prior to surgery, providing a nutritional
supplement to increase protein, leucine, vitamin D and omega-3 fatty acid FA intake with
a structured exercise program and relaxation techniques should improve muscle mass,
strength and physical performance.
MAIN OBJECTIVE: to test the effect of a multimodal RCT prehabilitation intervention (MM)
combining a mixed-nutrient supplement with structured exercise training or the supplement
alone (NUT) against a placebo (CTRL), on functional pre- and postoperative outcomes in
surgical patients with lung cancer at nutritional risk.
STUDY DESIGN: 10-week randomized controlled trial of 3 parallel arms, double-blinded for
supplement: control (CTRL), multi-nutrient supplement (NUT) and multimodal intervention
(MM). After baseline assessment, patients will be randomized to either group in a 1:1:1
CTRL:NUT:MM ratio using a computer-generated randomization scheme by permuted block
sizes, with stratification by sex and functional capacity (< or > 450 m on the 6-minute
walk test (6MWT). Consecutive adult patients = or > 45 years scheduled for elective
video-assisted thoracic surgery or open thoracotomy surgery of non-small cell lung cancer
(NSCLC) stages I, II or IIIa and a Patient-Generated Subjective Global Assessment
(PG-SGA) score = or > 3, will be approached following their first appointment with their
surgeon at the McGill University Health Centre (MUHC)-Montreal General Hospital.
INTERVENTION: The NUT arm will ingest a multi-nutrient supplement consisting of whey
protein + leucine + viatmin D, and fish oil. The CTRL participants will receive placebo
supplements with the same physical aspect, flavor and packaging as the active
supplement.The MM arm will receive the NUT intervention in addition to performing
structured exercise and relaxation techniques for 4 weeks prior to surgery and 6 weeks
after hospital discharge.
OUTCOMES: Primary: physical capacity measured by the 6MWT; Secondary: physical function,
muscle strength, total skeletal muscle mass, leg muscle volume and density, body
composition, quality of life, length of stay and post-operative complications; Other:
dietary intake, physical activity, exercise tolerance, pulmonary function, clinical
markers.
STATISTICAL ANALYSIS: Intention-to-treat analysis will be performed in the primary
analyses. For preoperative data, analysis of covariance (ANCOVA) will compare
between-group differences at 4-week preoperative time, conditioned for baseline data,
including predefined covariates in the model (age, sex, BMI). The hypothesis of full
recovery from the intervention at 6 weeks postoperative (i.e. 6MWT returning back to or
exceeding baseline) will be tested by logistic regression (yes/no). Between-group changes
in other outcomes will be evaluated as differences in mean or proportions, as
appropriate, with 95% CIs.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
45 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Institute of the McGill University Health Centre
Address:
City:
Montreal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Stéphanie Chevalier, PhD
Phone:
(514) 934-1934
Phone ext:
35019
Email:
stephanie.chevalier@mcgill.ca
Start date:
June 26, 2023
Completion date:
March 20, 2026
Lead sponsor:
Agency:
Stéphanie Chevalier
Agency class:
Other
Collaborator:
Agency:
Canadian Institutes of Health Research (CIHR)
Agency class:
Other
Source:
McGill University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05955248
