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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05636969
Study type Observational
Source Hospital Clinic of Barcelona
Contact Raquel Sebio, PhD
Phone +34634787194
Email sebio@clinic.cat
Status Recruiting
Phase
Start date June 10, 2023
Completion date June 1, 2025

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