Clinical trial NCT04610606: Pilot Prehabilitation Intervention in Lung Cancer
Official title: A Novel Multimodal Intervention for Surgical Prehabilitation of Patients With Lung Cancer: Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Surgery
Keywords: Prehabilitation
Nutritional supplement
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Peri-Operative Program Charitable Foundation
name: MUHC-Montreal General Hospital Foundation
First posted: 2020-10-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label, randomized, controlled trial of two parallel arms: multimodal intervention (MM) and standard of care (SOC).
Primary purpose: OTHER

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.

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 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 prehabilitation intervention (MM) combining a mixed-nutrient supplement with structured exercise training against standard of care (SOC), on functional pre- and postoperative outcomes in surgical patients with lung cancer, in an open-label RCT.

The present is a pilot study aiming to generate feasibility data (recruitment rate, compliance, attrition) and preliminary outcome data to support a larger trial.

STUDY DESIGN: Open-label, randomized, controlled trial of two parallel arms: multimodal intervention (MM) and standard of care (SOC). After baseline assessment, patients will be randomized to either group in a 1:2 SOC:MM ratio using a computer-generated randomization scheme by block of four, with stratification by sex and functional capacity (\< or \> 400 m on the 6MWT). Consecutive adult patients scheduled for elective video-assisted thoracic surgery or open thoracotomy surgery of NSCLC stages I, II or IIIa, will be approached following their first appointment with their surgeon at the MUHC-Montreal General Hospital.

INTERVENTION: The EXP arm will ingest a multi-nutrient supplement consisting of whey protein + leucine and fish oil + vitamin D, perform structured exercise and relaxation techniques for 4 weeks prior to surgery and 8 weeks after surgery. Control group will received standard hospital care and education on benefits of physical activity and healthy diet. Outcome assessment will be performed at baseline, preoperative, 4 and 8 weeks postoperatively.

OUTCOMES: Primary: feasibility; Secondary: physical function, muscle strength, volume and density, body composition, quality of life, length of stay and post-operative complications; Other: dietary intake, physical activity, clinical markers.

STATISTICAL ANALYSIS: This is a pilot study designed to generate data on feasibility and compliance to the intervention and study tests; it is not powered for identifying statistical differences in the main outcomes. The investigators will recruit 36 participants on a 1:2 ratio (12 SOC: 24 MM).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Feasibility: Recruitment rate
timeFrame: Over entire recruitment period (approximately 1 year)
measure: Feasibility: Adherence to intervention
timeFrame: Over 12 weeks (4 weeks pre- and 8 weeks post-surgery)
measure: Feasibility: completion of study outcome assessment
timeFrame: Over 12 weeks (4 weeks pre- and 8 weeks post-surgery)
Secondary outcomes:
measure: Functional walking capacity
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Length of hospital stay
timeFrame: 8-week postoperative
measure: Post-operative complications
timeFrame: 8-week postoperative
measure: Health related quality of life
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Quality of Life
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Muscle strength - handgrip
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Muscle strength - leg
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Muscle volume
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Muscle radiodensity
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Body composition
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Other outcomes:
measure: Dietary assessment
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Plasma phospholipid n-3 FA profile
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Serum 25(OH)D
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Inflammation
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Serum albumin
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Pre-albumin
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Hemoglobin
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Exercise tolerance - oxygen consumption
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Exercise tolerance - workload
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Exercise tolerance - heart rate
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Pulmonary function (FEV1)
timeFrame: Baseline and 4-week postoperative
measure: Pulmonary function (FVC)
timeFrame: Baseline and 4-week postoperative
measure: Pulmonary function (FEV1/FVC)
timeFrame: Baseline and 4-week postoperative
measure: Pulmonary function (FEF 25-75%)
timeFrame: Baseline and 4-week postoperative
measure: Physical activity
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Anxiety/depression
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
measure: Nutritional status
timeFrame: Baseline, preoperative, 4-week postoperative and 8-week postoperative
Locations:
city: Montréal
country: Canada
facility: Research Institute of the McGill University Health Centre
state: Quebec
Study officials:
affiliation: Research Institute of the McGill University Health Centre
name: Stéphanie Chevalier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.