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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05636969
• Other study ID #: HCB-TNA-2022
• Status: Recruiting
• Start date: June 10, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2024
• Source: Hospital Clinic of Barcelona
• Contact: Raquel Sebio, PhD
• Phone: +34634787194
• Email: sebio[@]clinic.cat
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Behavioral:
• Multimodal prehabilitation
Multimodal prehabilitation including i) exercise training and physical activity promotion; ii) nutritional counselling and supplementation if needed; iii) psychological support

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Consorci Hospitalari de Vic, Hospital de Granollers, Hospital de Mollet, TecnoCampus

Country where clinical trial is conducted

Spain, 

References & Publications (8)

Allen SK, Brown V, White D, King D, Hunt J, Wainwright J, Emery A, Hodge E, Kehinde A, Prabhu P, Rockall TA, Preston SR, Sultan J. Multimodal Prehabilitation During Neoadjuvant Therapy Prior to Esophagogastric Cancer Resection: Effect on Cardiopulmonary Exercise Test Performance, Muscle Mass and Quality of Life-A Pilot Randomized Clinical Trial. Ann Surg Oncol. 2022 Mar;29(3):1839-1850. doi: 10.1245/s10434-021-11002-0. Epub 2021 Nov 1. — View Citation

Brunelli A, Rocco G, Szanto Z, Thomas P, Falcoz PE. Morbidity and mortality of lobectomy or pneumonectomy after neoadjuvant treatment: an analysis from the ESTS database. Eur J Cardiothorac Surg. 2020 Apr 1;57(4):740-746. doi: 10.1093/ejcts/ezz287. — View Citation

Cabanero Sanchez A, Munoz Molina GM, Fra Fernandez S, Muriel Garcia A, Cilleruelo Ramos A, Martinez Hernandez N, Hernando Trancho F, Moreno Mata N; GE-VATS. Impact of neoadjuvant therapy on postoperative complications in non-small-cell lung cancer patients subjected to anatomic lung resection. Eur J Surg Oncol. 2022 Sep;48(9):1947-1953. doi: 10.1016/j.ejso.2022.03.008. Epub 2022 Mar 29. — View Citation

Connolly JG, Fiasconaro M, Tan KS, Cirelli MA Jr, Jones GD, Caso R, Mansour DE, Dycoco J, No JS, Molena D, Isbell JM, Park BJ, Bott MJ, Jones DR, Rocco G. Postinduction therapy pulmonary function retesting is necessary before surgical resection for non-small cell lung cancer. J Thorac Cardiovasc Surg. 2022 Aug;164(2):389-397.e7. doi: 10.1016/j.jtcvs.2021.12.030. Epub 2021 Dec 23. — View Citation

Granger C, Cavalheri V. Preoperative exercise training for people with non-small cell lung cancer. Cochrane Database Syst Rev. 2022 Sep 28;9(9):CD012020. doi: 10.1002/14651858.CD012020.pub3. — View Citation

Jack S, West MA, Raw D, Marwood S, Ambler G, Cope TM, Shrotri M, Sturgess RP, Calverley PM, Ottensmeier CH, Grocott MP. The effect of neoadjuvant chemotherapy on physical fitness and survival in patients undergoing oesophagogastric cancer surgery. Eur J Surg Oncol. 2014 Oct;40(10):1313-20. doi: 10.1016/j.ejso.2014.03.010. Epub 2014 Mar 27. — View Citation

Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment-related morbidity, increase cancer treatment options, and improve physical and psychological health outcomes. Am J Phys Med Rehabil. 2013 Aug;92(8):715-27. doi: 10.1097/PHM.0b013e31829b4afe. — View Citation

Sinclair R, Navidi M, Griffin SM, Sumpter K. The impact of neoadjuvant chemotherapy on cardiopulmonary physical fitness in gastro-oesophageal adenocarcinoma. Ann R Coll Surg Engl. 2016 Jul;98(6):396-400. doi: 10.1308/rcsann.2016.0135. Epub 2016 May 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adherence	Number of completed exercise sessions in the prehabilitation cohort versus number of scheduled sessions	1 week before surgery
Secondary	Adverse events	Number of adverse events registered during the exercise training sessions	1 week before surgery
Secondary	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
Secondary	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