Lung Cancer Clinical Trial
— MMP-LUNGOfficial title:
A Novel Multimodal Intervention for Surgical Prehabilitation of Patients With Lung Cancer: the MMP-LUNG 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.
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. |
Country | Name | City | State |
---|---|---|---|
Canada | Research Institute of the McGill University Health Centre | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Stéphanie Chevalier | Canadian Institutes of Health Research (CIHR) |
Canada,
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 |
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