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。

IF 3.4 3区 医学 Q1 RESPIRATORY SYSTEM
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
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引用次数: 0

摘要

肺癌是癌症相关死亡的主要原因。I-III期非小细胞肺癌(NSCLC)患者适合手术切除;然而,术前肌肉量低、肌骨化症、营养不良或功能减退的患者术后发病率较高。康复是一种旨在在手术前增强功能以改善手术效果的护理过程。研究目的是测试与安慰剂对照(CTL)相比,非小细胞肺癌患者术前和出院后功能能力、肌肉量和肌骨化症、术后健康相关生活质量(HRQoL)、并发症和住院时间的变化,单独使用混合营养补充剂(NUT)或与运动相结合的预康复干预(MM,多模式预康复)的影响。我们假设,无论是否进行锻炼,服用多种营养补充剂都是有益的。方法和分析:三个平行组的随机对照试验:168例有营养风险的可手术NSCLC患者按1:1:1随机分为CTL、NUT或MM组。NUT组和MM组的患者术前4-6周和出院后6周接受由乳清蛋白、亮氨酸、维生素D和鱼油组成的营养补充剂。运动计划(MM)包括每日中等强度有氧运动和阻力训练,每周3天。以下是在基线、术前和出院后第6周进行的评估:使用6分钟步行测试评估功能能力,使用d3 -肌酸稀释和外周定量CT评估肌肉质量和肌骨化症,使用癌症治疗-肺功能评估评估HRQoL。意向治疗协方差分析将比较经基线变量调整后的组间差异。术后功能恢复将通过逻辑回归进行检验。采用Bonferroni校正,对临床结果的组间差异进行测试。伦理和传播:该试验由麦吉尔大学健康中心研究伦理委员会(2022-7782)批准。研究结果将发表在开放获取的同行评审期刊和会议报告上。试验注册详情:NCT05955248。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

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).

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.

Trial registration details: NCT05955248.

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来源期刊
BMJ Open Respiratory Research
BMJ Open Respiratory Research RESPIRATORY SYSTEM-
CiteScore
6.60
自引率
2.40%
发文量
95
审稿时长
12 weeks
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.
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