Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05955248
Other study ID # MUHC REB 2022-7782
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 26, 2023
Est. completion date March 20, 2026

Study information

Verified date July 2023
Source McGill University
Contact Stéphanie Chevalier, PhD
Phone (514) 934-1934
Email stephanie.chevalier@mcgill.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 168
Est. completion date March 20, 2026
Est. primary completion date September 20, 2025
Accepts healthy volunteers No
Gender All
Age group 45 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Mixed-nutriend supplement (NUT)
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).
Other:
Multimodal Prehabilitation (MM)
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)
Dietary Supplement:
Placebo Control (CTRL)
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.

Locations

Country Name City State
Canada Research Institute of the McGill University Health Centre Montreal Quebec

Sponsors (2)

Lead Sponsor Collaborator
Stéphanie Chevalier Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in dietary intake Collected from 3-day food diaries, using a mobile application (Keenoa) From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Other Change in plasma phospholipid fatty acid profile Plasma lipids will be extracted with organic solvents, phospholipids isolated on thin-layer chromatography, and FAs methylated for determination by gas chromatography-flame-ionization analysis. Change in long-chain omega-3 fatty acids will be used as an objective measure of adherence to fish oil supplement. From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Other Change in serum vitamin D 25(OH)D concentrations Concentrations will be measured by the MUHC-Central Lab. Used as an objective measure of adherence to the supplement. From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Other Change in serum C-Reactive Protein (CRP) Measured as high-sensitive CRP by the MUHC-Central Lab. From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Other Change in serum albumin Analyzed by standard procedures at the MUHC-Central Lab From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Other Change in serum pre-albumin Analyzed by standard procedures at the MUHC-Central Lab From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Other Change in serum hemoglobin Analyzed by standard procedures at the MUHC-Central Lab From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Other Change in complete blood count Analyzed by standard procedures at the MUHC-Central Lab From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Other Change in preoperative exercise tolerance Assessed as oxygen consumption during cardiopulmonary exercise testing (CPET) at anaerobic threshold and peak exercise, in mL O2/kg/min From baseline (4 weeks pre-surgery) to surgery
Other Change in forced expiratory volume (FEV1) Spirometry standard methods to measure the forced expiratory volume (FEV1) From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Other Change in forced vital capacity (FVC) Spirometry standard methods to measure the forced vital capacity (FVC) and calculate FEV1/FVC ratio. From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Other Change in self-reported physical activity level score Measured with the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire, score 0 - x (no maximum score), higher mean more activity. From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Other Change in physical activity Measured by accelerometry (Actigraph wGT3X-BT) during the intervention. Step count and time spent at sedentary, light, moderate/ vigorous activity, and sleeping time will be recorded. From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Other Change in anxiety/depression score Hospital Anxiety and Depression Scale (questionnaire). Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Other Change in Patient-Generated Subjective Global Assessment (PG-SGA) score PG-SGA questionnaire, total score. A higher score indicates higher nutritional risk or malnutrition. From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Other Number of adverse events Any adverse event, related or not to the intervention Through study completion, an average of 10 weeks
Primary Change in preoperative functional walking capacity 6-Minute walking test (6MWT): measured as the distance walked during 6 minutes, along a 20-m corridor, expressed in meters From baseline (4 weeks pre-surgery) to surgery
Primary Postoperative functional walking capacity 6-Minute walking test (6MWT): measured as the distance walked during 6 minutes, along a 20-m corridor, expressed in meters 6 weeks after surgery
Secondary Change in handgrip strength Handgrip strength using hand-held Jamar dynamometer, measured in kg From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Secondary Change in total skeletal muscle mass Estimated using deuterium-labeled creatine (D3-creatine), measured in kg From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Secondary Change in foreleg muscle surface area Skeletal muscle surface area will be measured in the dominant foreleg, using peripheral quantitative computerized tomography (pQCT, Stratec XCT2000), measured in cm2. From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Secondary Change in foreleg myosteatosis (radiodensity) Skeletal muscle radiodensity will be measured in the dominant foreleg, using peripheral quantitative computerized tomography (pQCT, Stratec XCT2000), measured in mg/cm3. From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Secondary Change in body weight and composition Soft lean and fat mass measured by bioelectrical impedance (seca mBCA 515) From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Secondary Change in self-reported quality of life Measured by the 36-item Short Form Survey (SF36, score 0-100; higher means better quality of life) From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Secondary Change in self-reported functional assessment Measured by the Functional Assessment of Cancer Therapy - Lung questionnaire (FACT-L score 0-136, higher means better quality of life) From baseline (4 weeks pre-surgery) to 6 weeks after surgery
Secondary Length of hospital stay Recorded from medical charts, expressed in days 6 weeks after surgery
Secondary Number and severity of postoperative complications Recorded from medical charts and graded by severity following the Clavien-Dindo classification 6 weeks after surgery
See also
  Status Clinical Trial Phase
Completed NCT03918538 - A Series of Study in Testing Efficacy of Pulmonary Rehabilitation Interventions in Lung Cancer Survivors N/A
Recruiting NCT05078918 - Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors N/A
Active, not recruiting NCT04548830 - Safety of Lung Cryobiopsy in People With Cancer Phase 2
Completed NCT04633850 - Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05898594 - Lung Cancer Screening in High-risk Black Women N/A
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03575793 - A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients With Recurrent Small Cell Lung Cancer Phase 1/Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Terminated NCT01624090 - Mithramycin for Lung, Esophagus, and Other Chest Cancers Phase 2
Terminated NCT03275688 - NanoSpectrometer Biomarker Discovery and Confirmation Study
Not yet recruiting NCT04931420 - Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels Phase 2
Recruiting NCT06052449 - Assessing Social Determinants of Health to Increase Cancer Screening N/A
Recruiting NCT06010862 - Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors Phase 1
Not yet recruiting NCT06017271 - Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Recruiting NCT05787522 - Efficacy and Safety of AI-assisted Radiotherapy Contouring Software for Thoracic Organs at Risk