Effects of Multimodal Prehabilitation on Cardiorespiratory Fitness and Pulmonary Function During Neoadjuvant Therapy in Patients with Locally Advanced Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Changes in cardiorespiratory fitness assessed with a cardiopulmonary exercise test
研究概览
简要总结
Neoadjuvant therapy (NAT) with chemoimmunotherapy is currently indicated for patients with locoregional advanced non-small cell lung cancer (NSCLC) prior to resection surgery, but literature has suggested that this is associated with decreased pulmonary function and potentially cardiorespiratory fitness, leading to increased risk of postoperative complications. In this study, we aimed to: 1) compare the effects of NAT on cardiorespiratory fitness (VO2peak) and lung function (DLCO, FEV1 and FVC) in patients with locoregional lung cancer undergoing prehabilitation before lung resection surgery.
Secondary objectives included:
- To determine feasibility of the intervention (recruitment rate, competition rate and adherence) as well as safety (incidence of adverse events), particularly regarding the exercise component;
- To quantify the effects of the intervention in terms of functional capacity (1min Sit-to-Stand Test), mood (Hospital Anxiety and Depression Scale) and self-reported physical activity (Yale Physical Activity Survey).
- To assess the effects of multimodal prehabilitation on treatment completion (dose reductions/delays in planning/treatment withdrawal) as well as tolerability/toxicity (Coming Terminology Criteria for Adverse Events version 4.03) to chemo/immunotherapy
- To assess the effects of multimodal prehabilitation on surgical outcomes (postoperative complications based on the Comprehensive Complication Index (CCI) of the Clavien-Dindo Classification System and length of hospital stay).
- To determine the effect of the intervention on post-operative functional recovery by means of the 1-min Sit-To-Stand test conducted at hospital discharge.
In order to achieve this, we will conduct a prospective study including all patients with NSCLC scheduled for NAT (chemoimmunotherapy or chemotherapy alone) across four different hospitals in Spain and France. Patients will be identified from the multidisciplinary tumour board and will be subsequently referred to the oncologist consultation. After this, one of the members of the researchers will contact the patient and explain the purpose of the study. Those who are willing to participate, will be scheduled to undergo a CardioPulmonary Exercise Test (CPET) in addition to standard lung function tests (spirometry, diffusion capacity of carbon monoxide). After that, patients will be invited to participate in a multimodal prehabilitation program including supervised exercise training, home-based inspiratory muscle training, nutritional optimization and psychological support. Patients who refuse participation in the program due to logistic reasons, will be asked to serve as controls. In addition, we will also use data from a historical cohort including patients treated with chemoimmunotherapy prior to the implementation of the study as controls.
Patients will be assessed at baseline, after NAT and post-surgery (at hospital discharge).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors will be blinded to whether patients receiving prehabilitation or not for some outcome measures (complications, neoadjuvant-related outcomes). Researchers conducting analyses will be blinded to patient allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with diagnosed non-small celll lung cancer (NSCLC) undergoing neoadjuvant therapy before lung resection surgery
排除标准
- •Physical impairments that prevent patients to perform a CardioPulmonary Exercise Test
- •Non-resectable tumours
- •Patients who refuse either surgical resection or neoadjuvant therapy
研究组 & 干预措施
Control
Patients declining participation in the prehabilitation program will serve as controls and will receive standard recommendations to increase or maintain their physical activity levels and fitness during the neoadjuvant therapy
Prehabilitation
Patients in this group will attend a supervised multimodal prehabilitation programme
干预措施: Multimodal prehabilitation (Behavioral)
结局指标
主要结局
Changes in cardiorespiratory fitness assessed with a cardiopulmonary exercise test
时间窗: 2 weeks post-neoadjuvant therapy
Differences in maximum oxygen consumption (VO2pic) pre to post neoadjvuant therapy during an incremental, symptom-limited test
次要结局
- Changes in diffusion capacity of carbon monoxide (DLCO)(2 weeks post-neoadjuvant therapy)
- Changes in submaximal cardiorespiratory fitness assessed with a cardiopulmonary exercise test(2 weeks post-neoadjuvant therapy)
- Changes in ventilatory efficiency (VE/VCO2 slope) assessed during a cardiopulmonary exercise test(2 weeks post-neoadjuvant therapy)
- Changes in pulmonary function (FEV1)(2 weeks post-neoadjuvant therapy)
- Changes in pulmonary function (FVC)(2 weeks post-neoadjuvant therapy)
- Feasibility (recruitment rate ) of multimodal prehabilitation(1 week before surgery)
- Feasibility (completion rate) of multimodal prehabilitation(1 week before surgery)
- Adherence(1 week before surgery)
- Adverse events(1 week before surgery)
- Postoperative Complications(within 30 days of hospital discharge)
- 30-Day readmissions, re-interventions and emergency room visits(30 days after surgery)
- Chemoimmunotherapy completion rates(1 week post-neoadjuvant therapy)
- Post-surgery functional capacity(Same day as dicharge from hospital)
- Post-NAT functional capacity(2 weeks post-neoadjuvant therapy)
- Post-NAT mood(2 weeks post-neoadjuvant therapy)
- Post-NAT self-reported physical activity(2 weeks post-neoadjuvant therapy)
研究者
Graciela Martinez-Palli
Senior Consultant
Hospital Clinic of Barcelona