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NCT05636969
Assessment of Cardiorespiratory Fitness and Lung Function in Lung Cancer Patients Undergoing NAT
Conditions: Non Small Cell Lung Cancer
Sex: All
Ages: 18 Years – N/A
Enrollment: 25
Sponsor: Hospital Clinic of Barcelona
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.
Eligibility Criteria
Inclusion Criteria:Adult patients with diagnosed non-small celll lung cancer (NSCLC) undergoing neoadjuvant therapy before lung resection surgeryExclusion Criteria:Physical impairments that prevent patients to perform a CardioPulmonary Exercise TestNon-resectable tumoursPatients who refuse either surgical resection or neoadjuvant therapy
Source: ClinicalTrials.gov (NCT05636969). StuddyBuddy aggregates publicly available trial information.