Audrey Moyen, Chloé Fleurent-Grégoire, Chelsia Gillis, Roni Zaks, Francesco Carli, Celena Scheede-Bergdahl, Jonathan Spicer, Jonathan Cools-Lartigue, Sara Najmeh, José A Morais, Vera Mazurak, Stéphanie Chevalier
{"title":"非小细胞肺癌患者手术前康复功能恢复和肌肉特征的新型多模式干预:随机对照试验(MMP-LUNG)的研究方案。","authors":"Audrey Moyen, Chloé Fleurent-Grégoire, Chelsia Gillis, Roni Zaks, Francesco Carli, Celena Scheede-Bergdahl, Jonathan Spicer, Jonathan Cools-Lartigue, Sara Najmeh, José A Morais, Vera Mazurak, Stéphanie Chevalier","doi":"10.1136/bmjresp-2024-002884","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Lung cancer is the leading cause of cancer-related deaths. Patients with stage I-III non-small cell lung cancer (NSCLC) are candidates for surgical resection; however, patients with low muscle mass, myosteatosis, malnutrition or reduced functional capacity preoperatively have a higher risk of postoperative morbidity. Prehabilitation is a care process aiming to enhance functional capacity before surgery to improve surgical outcomes. Study objectives are to test the effect of prehabilitation interventions of a mixed-nutrient supplement (NUT) alone or its combination with exercise (MM, multimodal prehabilitation), compared with placebo-control (CTL), in NSCLC patients on change in functional capacity pre-surgery and post-discharge, muscle mass and myosteatosis, postoperative health-related quality of life (HRQoL), complications and length of hospital stay. We hypothesise that a multi-nutrient supplement, with or without exercise, will be of benefit.</p><p><strong>Methods and analysis: </strong>Randomised controlled trial of three parallel arms: 168 patients with operable NSCLC at nutritional risk are randomised 1:1:1 to CTL, NUT or MM. Patients in the NUT and MM groups receive a nutritional supplement consisting of whey protein, leucine, vitamin D and fish oil 4-6 weeks preoperatively and 6 weeks post-discharge. The exercise programme (MM) consists of daily moderate-intensity aerobic activity and resistance training 3 days/week. The following is assessed at baseline, preoperatively and week six post-discharge: functional capacity using the 6 min walk test, muscle mass and myosteatosis using D3-creatine dilution and peripheral quantitative CT, and HRQoL using the Functional Assessment of Cancer Therapy-Lung. Intention-to-treat analysis of covariance will compare between-group differences adjusted for baseline variables. Postoperative functional recovery will be tested by logistic regression. Between-group differences in clinical outcomes will be tested, applying Bonferroni correction.</p><p><strong>Ethics and dissemination: </strong>This trial is approved by the McGill University Health Centre Research Ethics Board (2022-7782). Results will be published in open-access peer-reviewed journals and conference presentations.</p><p><strong>Trial registration details: </strong>NCT05955248.</p>","PeriodicalId":9048,"journal":{"name":"BMJ Open Respiratory Research","volume":"12 1","pages":""},"PeriodicalIF":3.4000,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12097010/pdf/","citationCount":"0","resultStr":"{\"title\":\"Novel multimodal intervention for surgical prehabilitation on functional recovery and muscle characteristics in patients with non-small cell lung cancer: study protocol for a randomised controlled trial (MMP-LUNG).\",\"authors\":\"Audrey Moyen, Chloé Fleurent-Grégoire, Chelsia Gillis, Roni Zaks, Francesco Carli, Celena Scheede-Bergdahl, Jonathan Spicer, Jonathan Cools-Lartigue, Sara Najmeh, José A Morais, Vera Mazurak, Stéphanie Chevalier\",\"doi\":\"10.1136/bmjresp-2024-002884\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Lung cancer is the leading cause of cancer-related deaths. Patients with stage I-III non-small cell lung cancer (NSCLC) are candidates for surgical resection; however, patients with low muscle mass, myosteatosis, malnutrition or reduced functional capacity preoperatively have a higher risk of postoperative morbidity. Prehabilitation is a care process aiming to enhance functional capacity before surgery to improve surgical outcomes. Study objectives are to test the effect of prehabilitation interventions of a mixed-nutrient supplement (NUT) alone or its combination with exercise (MM, multimodal prehabilitation), compared with placebo-control (CTL), in NSCLC patients on change in functional capacity pre-surgery and post-discharge, muscle mass and myosteatosis, postoperative health-related quality of life (HRQoL), complications and length of hospital stay. We hypothesise that a multi-nutrient supplement, with or without exercise, will be of benefit.</p><p><strong>Methods and analysis: </strong>Randomised controlled trial of three parallel arms: 168 patients with operable NSCLC at nutritional risk are randomised 1:1:1 to CTL, NUT or MM. Patients in the NUT and MM groups receive a nutritional supplement consisting of whey protein, leucine, vitamin D and fish oil 4-6 weeks preoperatively and 6 weeks post-discharge. The exercise programme (MM) consists of daily moderate-intensity aerobic activity and resistance training 3 days/week. The following is assessed at baseline, preoperatively and week six post-discharge: functional capacity using the 6 min walk test, muscle mass and myosteatosis using D3-creatine dilution and peripheral quantitative CT, and HRQoL using the Functional Assessment of Cancer Therapy-Lung. Intention-to-treat analysis of covariance will compare between-group differences adjusted for baseline variables. Postoperative functional recovery will be tested by logistic regression. Between-group differences in clinical outcomes will be tested, applying Bonferroni correction.</p><p><strong>Ethics and dissemination: </strong>This trial is approved by the McGill University Health Centre Research Ethics Board (2022-7782). 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Novel multimodal intervention for surgical prehabilitation on functional recovery and muscle characteristics in patients with non-small cell lung cancer: study protocol for a randomised controlled trial (MMP-LUNG).
Introduction: Lung cancer is the leading cause of cancer-related deaths. Patients with stage I-III non-small cell lung cancer (NSCLC) are candidates for surgical resection; however, patients with low muscle mass, myosteatosis, malnutrition or reduced functional capacity preoperatively have a higher risk of postoperative morbidity. Prehabilitation is a care process aiming to enhance functional capacity before surgery to improve surgical outcomes. Study objectives are to test the effect of prehabilitation interventions of a mixed-nutrient supplement (NUT) alone or its combination with exercise (MM, multimodal prehabilitation), compared with placebo-control (CTL), in NSCLC patients on change in functional capacity pre-surgery and post-discharge, muscle mass and myosteatosis, postoperative health-related quality of life (HRQoL), complications and length of hospital stay. We hypothesise that a multi-nutrient supplement, with or without exercise, will be of benefit.
Methods and analysis: Randomised controlled trial of three parallel arms: 168 patients with operable NSCLC at nutritional risk are randomised 1:1:1 to CTL, NUT or MM. Patients in the NUT and MM groups receive a nutritional supplement consisting of whey protein, leucine, vitamin D and fish oil 4-6 weeks preoperatively and 6 weeks post-discharge. The exercise programme (MM) consists of daily moderate-intensity aerobic activity and resistance training 3 days/week. The following is assessed at baseline, preoperatively and week six post-discharge: functional capacity using the 6 min walk test, muscle mass and myosteatosis using D3-creatine dilution and peripheral quantitative CT, and HRQoL using the Functional Assessment of Cancer Therapy-Lung. Intention-to-treat analysis of covariance will compare between-group differences adjusted for baseline variables. Postoperative functional recovery will be tested by logistic regression. Between-group differences in clinical outcomes will be tested, applying Bonferroni correction.
Ethics and dissemination: This trial is approved by the McGill University Health Centre Research Ethics Board (2022-7782). Results will be published in open-access peer-reviewed journals and conference presentations.
期刊介绍:
BMJ Open Respiratory Research is a peer-reviewed, open access journal publishing respiratory and critical care medicine. It is the sister journal to Thorax and co-owned by the British Thoracic Society and BMJ. The journal focuses on robustness of methodology and scientific rigour with less emphasis on novelty or perceived impact. BMJ Open Respiratory Research operates a rapid review process, with continuous publication online, ensuring timely, up-to-date research is available worldwide. The journal publishes review articles and all research study types: Basic science including laboratory based experiments and animal models, Pilot studies or proof of concept, Observational studies, Study protocols, Registries, Clinical trials from phase I to multicentre randomised clinical trials, Systematic reviews and meta-analyses.