Assessment of Cardiorespiratory Fitness and Lung Function in Lung Cancer Patients Undergoing NAT

Study Overview
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Brief Summary
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Neoadjuvant therapy (NAT) is currently indicated for patients with locoregional advanced non-small cell lung cancer (NSCLC) prior to resection surgery, but literature has suggest that this is associated with decreased pulmonary function and potentially cardiorespiratory fitness, leading to an increased risk of postoperative complications. In this study, we aimed to 1) assess the effects of NAT on cardiorespiratory fitness and pulmonary function in patients with potentially resectable NSCLC and 2) to analyse the feasibility and preliminary effectiveness of multimodal prehabilitation to mitigate the effects of NAT on both cardiorespiratory fitness and pulmonary function. In order to do this, we will conduct an observational study including all patients with NSCLC scheduled for NAT at a tertiary hospital in Barcelona, Spain. Patients will be selected from the multidisciplinary tumour board and will be referred to undergoing both lung function tests (spirometry, diffusion capacity of carbon monoxide) and a CardioPulmonary Exercise Test (CPET). All patients will be invited to participate in a multimodal prehabilitation programme during NAT; those who agree will be further assessed by the multidisciplinary team at the Prehab Unit and will undergo a twice weekly, supervised exercise training programme for the total duration of NAT (approximately 12 weeks), as well as receive nutritional and psychological support. Patients who decline participation in the multimodal programme will act as a control cohort. Both cohorts will be reassessed after NAT before scheduled surgery. All analysis will be conducted adjusting for potential covariates and baseline differences between groups.

Official Title
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Assessment of Cardiorespiratory Fitness and Lung Function in Lung Cancer Patients Undergoing Neoadjuvant Cancer Therapy and Role of Prehabilitation in Preventing Associated Decline

Conditions
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Non Small Cell Lung Cancer

Intervention / Treatment
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* Behavioral: Multimodal prehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with diagnosed non-small celll lung cancer (NSCLC) undergoing neoadjuvant therapy before lung resection surgery Exclusion Criteria: Physical impairments that prevent patients to perform a CardioPulmonary Exercise Test Non-resectable tumours Patients who refuse either surgical resection or neoadjuvant therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prehabilitation<br>Patients in this cohort will undergo baseline and post-NAT pulmonary function test (spirometry, diffusion capacity of carbon monoxide) and cardiorespiratory fitness assessment (CPET). In addition, they will attend a multimodal prehabilitation programme consisted of 1) twice weekly, supervised exercise training at the hospital gym for approximately 12 weeks; 2) nutritional consultation and optimization if needed; 3) individual or group-based psychological support. | Behavioral: Multimodal prehabilitation<br>* Multimodal prehabilitation including i) exercise training and physical activity promotion; ii) nutritional counselling and supplementation if needed; iii) psychological support<br>|
| Control<br>Patients in the control cohort would undergo baseline and post-NAT pulmonary function test and cardiorespiratory fitness assessment (CPET). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cardiorespiratory fitness assessed with a cardiopulmonary exercise test | Differences in maximum oxygen consumption (VO2pic) pre to post neoadjvuant therapy during an incremental, symptom-limited test | 2 weeks post-neoadjuvant therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in diffusion capacity of carbon monoxide (DLCO) | Differences in diffusion capacity of carbon monoxide pre to post-neoadjuvant therapy | 2 weeks post-neoadjuvant therapy | 
| Changes in submaximal cardiorespiratory fitness assessed with a cardiopulmonary exercise test | Differences in oxygen consumption at the anaerobic threshold (VO2AT) pre to post-neoadjuvant therapy during an incremental, symptom-limited test | 2 weeks post-neoadjuvant therapy | 
| Changes in ventilatory efficiency (VE/VCO2 slope) assessed during a cardiopulmonary exercise test | Changes in ventilatory efficiency (VE/VCO2 slope) pre to post-neoadjuvant therapy | 2 weeks post-neoadjuvant therapy | 
| Changes in pulmonary function (FEV1) | Differences observed in the maximum volume achieved during the first second (FEV1) of a forced spirometry test, pre to post-neoadjuvant therapy | 2 weeks post-neoadjuvant therapy | 
| Changes in pulmonary function (FVC) | Differences observed in the forced ventilatory capacity (FVC) of a forced spirometry test, pre to post-neoadjuvant therapy | 2 weeks post-neoadjuvant therapy | 
| Feasibility (recruitment rate ) of multimodal prehabilitation | Feasibility of the multimodal prehabilitation programme assessed by the recruitment rate (number of patients attending prehabilitation versus number of eligible patients) | 1 week before surgery | 
| Feasibility (completion rate) of multimodal prehabilitation | Feasibility of the multimodal prehabilitation programme assessed by the completion rate (number of completers among those who accepted to participate in the programme) | 1 week before surgery | 
| Adherence | Number of completed exercise sessions in the prehabilitation cohort versus number of scheduled sessions | 1 week before surgery | 
| Adverse events | Number of adverse events registered during the exercise training sessions | 1 week before surgery | 
| Postoperative Complications | Number and severity of postoperative complications will be assessed by reviewing medical records and calculating the Comprehensive Complication Index (CCI) according to the Clavien-Dindo Classification. | 1 day of hospital discharge | 
| 30-Day readmissions, re-interventions and emergency room visits | Readmissions, surgical re-interventions and emergency room visits post-discharge and during the first 30 days will be recorded by reviewing medical records | 30 days post-surgery |