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Multimodal Prehabilitation for Lung Cancer Surgery (MMP-LUNG Trial)
N/A
Recruiting
Led By Stéphanie Chevalier, PhD
Research Sponsored by Stéphanie Chevalier
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with NSCLC stages I, II or IIIa and scheduled for video-assisted thoracic surgery (VATS) or open thoracotomy surgery for cancer resection
Adults aged 45 years and over
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (4 weeks pre-surgery) to 6 weeks after surgery
Awards & highlights
MMP-LUNG Trial Summary
This trial will test if a supplement with exercise improves outcomes for lung cancer patients pre- and post-surgery. Primary outcome is functional capacity, secondary outcomes include muscle mass, quality of life, length of stay, etc.
Who is the study for?
This trial is for adults over 45 with early-stage lung cancer (NSCLC stages I, II or IIIa) who are at nutritional risk and scheduled for specific types of lung surgery. They must be able to exercise and not already taking certain supplements. People with severe kidney issues, recent chemo or radiotherapy, allergies to milk/seafood, or language barriers can't join.Check my eligibility
What is being tested?
The study tests if a special program before and after lung cancer surgery helps patients recover better. It includes a mixed-nutrient supplement plus exercise training (MM), just the supplement (NUT), or a placebo (CTRL). The main goal is to see if this improves how far patients can walk in six minutes.See study design
What are the potential side effects?
Possible side effects may include reactions related to the nutrient supplement such as digestive discomfort or allergic responses in those sensitive to ingredients like milk or seafood.
MMP-LUNG Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have early-stage lung cancer and am scheduled for surgery to remove it.
Select...
I am 45 years old or older.
MMP-LUNG Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in preoperative functional walking capacity
Postoperative functional walking capacity
Secondary outcome measures
Change in body weight and composition
Change in foreleg muscle surface area
Change in foreleg myosteatosis (radiodensity)
+6 moreOther outcome measures
Change in Patient-Generated Subjective Global Assessment (PG-SGA) score
Change in anxiety/depression score
Change in complete blood count
+13 moreMMP-LUNG Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Multi-modal intervention (MM)Active Control2 Interventions
Multimodal prehabilitation including structured exercise (1 supervised exercise session per week + home-based exercise program), nutritional optimization with dietician, NUT intervention, and relaxation strategies.
Group II: Mixed-nutriend supplement (NUT)Active Control1 Intervention
Mixed nutrient supplement containing whey protein, leucine, vitamin D and omega 3 fatty acids
Group III: Control (CTRL)Placebo Group1 Intervention
Participants will be treated following Enhanced Recovery After Surgery (ERAS) protocols + placebo supplements containing maltodextrin and sunflower oil
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Who is running the clinical trial?
Stéphanie ChevalierLead Sponsor
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,399 Total Patients Enrolled
3 Trials studying Surgery
177 Patients Enrolled for Surgery
Stéphanie Chevalier, PhDPrincipal InvestigatorMcGill University
2 Previous Clinical Trials
54 Total Patients Enrolled
1 Trials studying Surgery
34 Patients Enrolled for Surgery
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are at risk for malnutrition, as determined by a specific assessment score.I have early-stage lung cancer and am scheduled for surgery to remove it.I have had recent chemo or radiotherapy within the last 2 months.I am willing to stop taking omega-3 supplements but can continue vitamin D unless my levels are too high.I use a wheelchair and cannot walk.You are not able to do physical exercise due to health problems.Your blood calcium levels are too high.You are allergic to milk or seafood.My kidney function is low.I am 45 years old or older.Your blood has too much vitamin D (more than 375 nmol/L).
Research Study Groups:
This trial has the following groups:- Group 1: Multi-modal intervention (MM)
- Group 2: Control (CTRL)
- Group 3: Mixed-nutriend supplement (NUT)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many volunteers are participating in this medical research endeavor?
"Indeed, the clinical trial is still enrolling according to the information available on clinicaltrials.gov. Its initial posting was June 26th 2023 and it has been adjusted as recently as July 12th of this year. The study requires 168 participants from a single location."
Answered by AI
Does this medical study currently welcome enrollees?
"Affirmative. The clinical trial listing on the website of clinicaltrials.gov states that, since its first posting on June 26th 2023 and last update on July 12th 2023, this medical study is recruiting 168 participants from a single site."
Answered by AI
What is the ultimate aim of this experiment?
"The primary intention of this medical study, to be evaluated six weeks post-surgery, is to assess changes in the preoperative functional walking capabilities. Secondary metrics include alterations in foreleg myosteatosis (radiodensity) as gauged by Stratec XCT2000 pQCT technology, fluctuations in body weight and composition with bioelectrical impedance tests via a seca mBCA 515 device, and length of hospitalisation which will be documented from patient records."
Answered by AI
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