Multimodal Prehabilitation for Lung Cancer Surgery

(MMP-LUNG Trial)

Overseen By Stéphanie Chevalier, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stéphanie Chevalier

Disqualifiers: Recent adjuvant therapy, Unable to walk, Allergy, Hypercalcemia, others

Compensation: Varies

Number of Visits: 1

168 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking omega-3 supplements during the study. If you are taking vitamin D, you can continue unless your vitamin D levels are too high. The protocol does not specify other medications.

What data supports the effectiveness of the treatment Multimodal Prehabilitation for Lung Cancer Surgery?

Research shows that multimodal prehabilitation, which includes nutrition and exercise, can improve functional capacity and reduce postoperative complications in lung cancer patients. Malnourished patients, in particular, benefit significantly from this approach, showing the greatest improvements. ^{1 2 3 4 5}

Is multimodal prehabilitation safe for humans?

In a study involving lung cancer patients, multimodal prehabilitation, which includes nutritional supplements and exercise, was generally well-tolerated with high adherence rates. However, 16% of participants reported side effects, indicating that while it is mostly safe, some individuals may experience minor issues. ^{1 2 3 6 7}

How does the multimodal prehabilitation treatment for lung cancer surgery differ from other treatments?

Multimodal prehabilitation for lung cancer surgery is unique because it combines exercise, nutritional support, and psychological preparation before surgery to improve patients' physical condition and reduce complications. This approach is different from standard treatments that typically focus on post-surgery recovery, as it aims to enhance patients' overall health and readiness for surgery, potentially leading to better outcomes. ^{1 2 3 8 9}

What is the purpose of this trial?

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.

Research Team

Stéphanie Chevalier, PhD

Principal Investigator

McGill University

Eligibility Criteria

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.

Inclusion 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 am 45 years old or older.

Exclusion Criteria

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.

Insufficient understanding of English or French to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants receive a multimodal prehabilitation intervention including a mixed-nutrient supplement and structured exercise training for 4 weeks prior to surgery

4 weeks

1 supervised exercise session per week + home-based exercise program

Postoperative Intervention

Participants continue the intervention with a focus on recovery, including the same multimodal approach for 6 weeks after hospital discharge

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mixed-nutrient supplement (NUT)
• Multimodal Prehabilitation (MM)
• Placebo Control (CTRL)

Trial Overview 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.

Participant Groups

Group I: Multi-modal intervention (MM) Active Control 2 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 Control 1 Intervention

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

Group III: Control (CTRL) Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Stéphanie Chevalier

Lead Sponsor

Trials

1

Recruited

170+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

Multimodal prehabilitation, which includes both nutrition and exercise, can improve functional walking capacity and pulmonary function in lung cancer patients before surgery, although it does not seem to affect postoperative outcomes.

A nutrition-only intervention showed a significant reduction in postoperative complications, suggesting that optimizing preoperative nutrition may provide important benefits that need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of preoperative nutrition and multimodal prehabilitation on functional capacity and postoperative complications in surgical lung cancer patients: a systematic review. Ferreira, V., Lawson, C., Ekmekjian, T., et al.[2021]

Over half of the lung cancer patients studied (51.2%) were classified as low-nutrition-risk, with those at high-nutrition-risk showing significantly lower baseline functional capacity, as measured by the 6-minute walk test (6MWT).

Patients with high-nutrition-risk who underwent multimodal prehabilitation experienced substantial improvements in functional capacity, with an average increase of 58.9 meters in the 6MWT, indicating that prehabilitation can be particularly beneficial for those at higher nutritional risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Malnourished lung cancer patients have poor baseline functional capacity but show greatest improvements with multimodal prehabilitation. Ferreira, V., Lawson, C., Gillis, C., et al.[2021]

A pilot study involving 34 early-stage lung cancer patients showed that a multimodal prehabilitation program, which included nutritional supplements and exercise, is feasible and well-accepted, with high adherence rates (86% for exercise and 93% for supplements).

While the prehabilitation program successfully increased dietary intake of key nutrients like protein and omega-3 fatty acids, it did not result in significant changes in muscle characteristics, indicating the need for further research in a larger trial to assess functional and post-operative outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of multimodal prehabilitation on muscle size, myosteatosis, and dietary intake of surgical patients with lung cancer - a randomized feasibility study. Lawson, C., Ferreira, V., Carli, F., et al.[2022]

Nutritional prehabilitation, whether alone or combined with exercise, significantly reduced the length of hospital stay by an average of 2 days for patients undergoing colorectal surgery, based on a review of 9 studies involving 914 patients.

Multimodal prehabilitation showed promising improvements in functional recovery, as indicated by better performance on the 6-minute walk test at 4 and 8 weeks post-surgery, although the evidence was limited due to methodological differences in the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Nutritional Prehabilitation, With and Without Exercise, on Outcomes of Patients Who Undergo Colorectal Surgery: A Systematic Review and Meta-analysis. Gillis, C., Buhler, K., Bresee, L., et al.[2022]

Prehabilitation, which includes behavioral interventions like smoking cessation and structured exercise training, is crucial for optimizing the health of moderate-to-high-risk surgical patients before lung cancer surgery, potentially reducing postoperative complications.

Evidence shows that multimodal prehabilitation programs, which combine education, nutritional support, and physical training, are more effective than single interventions in enhancing patients' aerobic fitness and overall recovery, leading to shorter hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How can we minimize the risks by optimizing patient's condition shortly before thoracic surgery? Ellenberger, C., Schorer, R., Bedat, B., et al.[2021]

In a study involving 185 participants, those who underwent multimodal prehabilitation (exercise, nutrition, and anxiety coping techniques) showed significant improvements in walking capacity before and after colorectal surgery compared to those who only received rehabilitation after surgery.

The prehabilitation group had a higher percentage of patients (60%) experiencing significant improvements in physical fitness, demonstrating that preoperative conditioning can enhance functional capacity and recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal prehabilitation improves functional capacity before and after colorectal surgery for cancer: a five-year research experience. Minnella, EM., Bousquet-Dion, G., Awasthi, R., et al.[2017]

In a study of colorectal and esophageal cancer patients undergoing the Fit4Surgery prehabilitation program, 56.3% achieved the target protein intake of ≥1.5 g/kg body weight per day, indicating good adherence to the nutritional intervention.

Mean daily protein intake significantly increased from 1.20 g/kg to 1.61 g/kg after prehabilitation, demonstrating that dietary counseling and whey protein supplementation effectively enhance nutritional status before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to and Efficacy of the Nutritional Intervention in Multimodal Prehabilitation in Colorectal and Esophageal Cancer Patients. van Exter, SH., Drager, LD., van Asseldonk, MJMD., et al.[2023]

Prehabilitation, which focuses on enhancing physical wellness through exercise, nutrition, and psychological support, is gaining popularity as a strategy to reduce complications in patients undergoing lung cancer surgery.

By improving patients' physical condition before surgery, prehabilitation may lead to better post-operative outcomes, particularly for frail individuals, and is being integrated into Enhanced Recovery After Surgery protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation: a narrative review focused on exercise therapy for the prevention of postoperative pulmonary complications following lung resection. Bingül, ES., Şentürk, NM., Kaynar, AM.[2023]

The study aims to evaluate the cost-effectiveness of a multimodal prehabilitation program for lung cancer patients undergoing thoracic surgery, focusing on enhancing functional status and reducing postoperative complications.

Using a Quadruple Aim approach, the research will assess patient and professional experiences, health outcomes like hospital stay duration and complication rates, and overall healthcare costs, contributing to a better understanding of prehabilitation benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of a technology-supported multimodal prehabilitation program in moderate-to-high risk patients undergoing lung cancer resection: randomized controlled trial protocol. Barberan-Garcia, A., Navarro-Ripoll, R., Sánchez-Lorente, D., et al.[2020]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Effects of preoperative nutrition and multimodal prehabilitation on functional capacity and postoperative complications in surgical lung cancer patients: a systematic review. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Malnourished lung cancer patients have poor baseline functional capacity but show greatest improvements with multimodal prehabilitation. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

Effects of multimodal prehabilitation on muscle size, myosteatosis, and dietary intake of surgical patients with lung cancer - a randomized feasibility study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Nutritional Prehabilitation, With and Without Exercise, on Outcomes of Patients Who Undergo Colorectal Surgery: A Systematic Review and Meta-analysis. [2022]

5. India pubmed.ncbi.nlm.nih.gov

How can we minimize the risks by optimizing patient's condition shortly before thoracic surgery? [2021]

6. England pubmed.ncbi.nlm.nih.gov

Multimodal prehabilitation improves functional capacity before and after colorectal surgery for cancer: a five-year research experience. [2017]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Adherence to and Efficacy of the Nutritional Intervention in Multimodal Prehabilitation in Colorectal and Esophageal Cancer Patients. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Prehabilitation: a narrative review focused on exercise therapy for the prevention of postoperative pulmonary complications following lung resection. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of a technology-supported multimodal prehabilitation program in moderate-to-high risk patients undergoing lung cancer resection: randomized controlled trial protocol. [2020]