Assessment of Cardiorespiratory Fitness and Lung Function in Lung Cancer Patients Undergoing NAT
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Prehabilitation 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
Multimodal prehabilitation including i) exercise training and physical activity promotion; ii) nutritional counselling and supplementation if needed; iii) psychological support
|
| Control Patients in the control cohort would undergo baseline and post-NAT pulmonary function test and cardiorespiratory fitness assessment (CPET). |
Outcome Measures
Primary Outcome Measures
- Changes in cardiorespiratory fitness assessed with a cardiopulmonary exercise test [2 weeks post-neoadjuvant therapy]
Differences in maximum oxygen consumption (VO2pic) pre to post neoadjvuant therapy during an incremental, symptom-limited test
Secondary Outcome Measures
- Changes in diffusion capacity of carbon monoxide (DLCO) [2 weeks post-neoadjuvant therapy]
Differences in diffusion capacity of carbon monoxide pre to post-neoadjuvant therapy
- Changes in submaximal cardiorespiratory fitness assessed with a cardiopulmonary exercise test [2 weeks post-neoadjuvant therapy]
Differences in oxygen consumption at the anaerobic threshold (VO2AT) pre to post-neoadjuvant therapy during an incremental, symptom-limited test
- Changes in ventilatory efficiency (VE/VCO2 slope) assessed during a cardiopulmonary exercise test [2 weeks post-neoadjuvant therapy]
Changes in ventilatory efficiency (VE/VCO2 slope) pre to post-neoadjuvant therapy
- Changes in pulmonary function (FEV1) [2 weeks post-neoadjuvant therapy]
Differences observed in the maximum volume achieved during the first second (FEV1) of a forced spirometry test, pre to post-neoadjuvant therapy
- Changes in pulmonary function (FVC) [2 weeks post-neoadjuvant therapy]
Differences observed in the forced ventilatory capacity (FVC) of a forced spirometry test, pre to post-neoadjuvant therapy
- Feasibility (recruitment rate ) of multimodal prehabilitation [1 week before surgery]
Feasibility of the multimodal prehabilitation programme assessed by the recruitment rate (number of patients attending prehabilitation versus number of eligible patients)
- Feasibility (completion rate) of multimodal prehabilitation [1 week before surgery]
Feasibility of the multimodal prehabilitation programme assessed by the completion rate (number of completers among those who accepted to participate in the programme)
- Adherence [1 week before surgery]
Number of completed exercise sessions in the prehabilitation cohort versus number of scheduled sessions
- Adverse events [1 week before surgery]
Number of adverse events registered during the exercise training sessions
- Postoperative Complications [1 day of hospital discharge]
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.
- 30-Day readmissions, re-interventions and emergency room visits [30 days post-surgery]
Readmissions, surgical re-interventions and emergency room visits post-discharge and during the first 30 days will be recorded by reviewing medical records
Eligibility Criteria
Criteria
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
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Non-resectable tumours
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Patients who refuse either surgical resection or neoadjuvant therapy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hospital Clinic of Barcelona
- TecnoCampus
- Hospital de Mollet
- Hospital de Granollers
- Consorci Hospitalari de Vic
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- HCB-TNA-2022