Pilot Prehabilitation Intervention in Lung Cancer

NCT04610606 | Terminated

• 1 other identifier: MUHC REB 2020-5633
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is the second most prevalent cancer in Canada and the leading cause of cancer-related mortality worldwide. Patients diagnosed at earlier (non-metastatic) stages are potential candidates for surgical tumor removal. However, they often present with poor nutritional status and physical function adding to the major catabolic stress imposed by surgery that negatively impacts recovery and survival after surgery. The purpose of this study is to investigate the potential benefits of a prehabilitation program that includes a combined nutritional supplement (whey protein, leucine, vitamin D and omega-3 fatty acids) with exercise and relaxation techniques for 4 weeks before surgery and continued for 8 weeks after surgery on functional pre- and postoperative outcomes, versus standard hospital care (control). Investigators will study whether the prehabilitation program improves physical performance, muscle mass and quality of life in patients undergoing lung cancer resection. The specific objective of this pilot study is to test feasibility and adherence to intervention, and generate pilot data to inform the design of a larger trial.

Conditions

Lung Cancer; Surgery

Keywords

Prehabilitation; Nutritional supplement

Outcome Measures

Primary Outcomes (3)

• Feasibility: Recruitment rate

  Recruitment rate (measured in percent, compared to expected rates)

  Over entire recruitment period (approximately 1 year)

• Feasibility: Adherence to intervention

  Adherence to exercise and nutritional interventions (measured in percent, compared to expected rates)

  Over 12 weeks (4 weeks pre- and 8 weeks post-surgery)

• Feasibility: completion of study outcome assessment

  Completion of study outcome assessments (measured in percent, compared to expected rates)

  Over 12 weeks (4 weeks pre- and 8 weeks post-surgery)

Secondary Outcomes (10)

• Functional walking capacity

  Baseline, preoperative, 4-week postoperative and 8-week postoperative

• Length of hospital stay

  8-week postoperative

• Post-operative complications

  8-week postoperative

• Health related quality of life

  Baseline, preoperative, 4-week postoperative and 8-week postoperative

• Quality of Life

  Baseline, preoperative, 4-week postoperative and 8-week postoperative

Other Outcomes (17)

• Dietary assessment

  Baseline, preoperative, 4-week postoperative and 8-week postoperative

• Plasma phospholipid n-3 FA profile

  Baseline, preoperative, 4-week postoperative and 8-week postoperative

• Serum 25(OH)D

  Baseline, preoperative, 4-week postoperative and 8-week postoperative

Study Arms (2)

Multimodal intervention (MM)

EXPERIMENTAL

Multimodal prehabilitation including structured exercise (1 supervised exercise session per week + home-based exercise program), nutritional optimization (diet + mixed nutrient supplement containing whey protein, leucine, vitamin D and omega 3 fatty acids) and relaxation strategies.

Behavioral: Multimodal intervention (MM)

Standard of care (SOC)

NO INTERVENTION

Education on benefits of physical activity and healthy diet, with no specific information.

Interventions

Multimodal intervention (MM) BEHAVIORAL

Exercise: Moderate intensity resistance and aerobic exercise, including one weekly supervised session and a home-based program. Participants were asked to 1) accumulate 30 min of aerobic exercise per day of their preferred type (ex. walking) and 2) perform 30 min of resistance exercise targeting major muscle groups, every second day for 2 sets of 8-12 reps. Nutrition: Optimize diet with protein-rich foods to meet protein intake of \>1.2 g/kg/d and energy of 25-30 kcal/kg/d. The supplement consists of whey protein isolate (with the goal of reaching 1.5 g/kg/d, providing 25 g/meal), 6g of leucine, fruit-flavored fish oil added with vitamin D. Relaxation strategies: private consultations with psychology-trained personnel whereby techniques aimed at reducing anxiety are practiced. Participants are also provided with a compact disc with relaxation exercises to be used at home 2-3 times per week.

Multimodal intervention (MM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult men and women with NSCLC stages I, II or IIIa, planned for video-assisted thoracic surgery (VATS) or open thoracotomy surgery for cancer resection or exploration.

You may not qualify if:

• prior recent (\<3 mo) chemotherapy, comorbidities contraindicating exercise (defined as CPET \<10 mL O2/kg/min), walking aids other than a cane, glomerular filtration rate \<30 mL/min/m2, allergy to milk or seafoods, chronic use of anti-coagulants, hypercalcemia, hypervitaminosis D, insufficient understanding of English or French language to provide informed consent. All medications and co-morbidities will be recorded. Patients taking vitamin D will continue their supplements; risk of potential overdosing will be monitored by serum 25(OH)D levels \>80 nmol/L. Those taking n-3 FA supplements will be asked to withhold during the study.

Sponsors & Collaborators

• McGill University: lead
• Peri-Operative Program Charitable Foundation: collaborator
• MUHC-Montreal General Hospital Foundation: collaborator

Study Sites (1)

Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (1)

• Lawson C, Ferreira V, Carli F, Chevalier S. Effects of multimodal prehabilitation on muscle size, myosteatosis, and dietary intake of surgical patients with lung cancer - a randomized feasibility study. Appl Physiol Nutr Metab. 2021 Nov;46(11):1407-1416. doi: 10.1139/apnm-2021-0249. Epub 2021 Jul 15.

  PMID: 34265218 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Stéphanie Chevalier, PhD

  Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Open-label, randomized, controlled trial of two parallel arms: multimodal intervention (MM) and standard of care (SOC).

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 30, 2020
• Study Start: October 11, 2019
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)