Multimodal Prehabilitation in Patients with Lung Cancer Undergoing Neoadjuvant Therapy
NCT ID: NCT05636969
Last Updated: 2025-03-19
Study Results
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Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-06-10
2027-06-01
Brief Summary
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Secondary objectives included:
1. To determine feasibility of the intervention (recruitment rate, competition rate and adherence) as well as safety (incidence of adverse events), particularly regarding the exercise component;
2. To quantify the effects of the intervention in terms of functional capacity (1min Sit-to-Stand Test), mood (Hospital Anxiety and Depression Scale) and self-reported physical activity (Yale Physical Activity Survey).
3. To assess the effects of multimodal prehabilitation on treatment completion (dose reductions/delays in planning/treatment withdrawal) as well as tolerability/toxicity (Coming Terminology Criteria for Adverse Events version 4.03) to chemo/immunotherapy
4. To assess the effects of multimodal prehabilitation on surgical outcomes (postoperative complications based on the Comprehensive Complication Index (CCI) of the Clavien-Dindo Classification System and length of hospital stay).
5. To determine the effect of the intervention on post-operative functional recovery by means of the 1-min Sit-To-Stand test conducted at hospital discharge.
In order to achieve this, we will conduct a prospective study including all patients with NSCLC scheduled for NAT (chemoimmunotherapy or chemotherapy alone) across four different hospitals in Spain and France. Patients will be identified from the multidisciplinary tumour board and will be subsequently referred to the oncologist consultation. After this, one of the members of the researchers will contact the patient and explain the purpose of the study. Those who are willing to participate, will be scheduled to undergo a CardioPulmonary Exercise Test (CPET) in addition to standard lung function tests (spirometry, diffusion capacity of carbon monoxide). After that, patients will be invited to participate in a multimodal prehabilitation program including supervised exercise training, home-based inspiratory muscle training, nutritional optimization and psychological support. Patients who refuse participation in the program due to logistic reasons, will be asked to serve as controls. In addition, we will also use data from a historical cohort including patients treated with chemoimmunotherapy prior to the implementation of the study as controls.
Patients will be assessed at baseline, after NAT and post-surgery (at hospital discharge).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Prehabilitation
Patients in this group will attend a supervised multimodal prehabilitation programme
Multimodal prehabilitation
The multimodal prehabilitation programme will consist of 1) twice weekly, supervised exercise training at the hospital gym for approximately 12-16 weeks; 2) nutritional consultation and diet optimization and supplementation if needed; 3) individual or group-based psychological support.
Control
Patients declining participation in the prehabilitation program will serve as controls and will receive standard recommendations to increase or maintain their physical activity levels and fitness during the neoadjuvant therapy
No interventions assigned to this group
Interventions
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Multimodal prehabilitation
The multimodal prehabilitation programme will consist of 1) twice weekly, supervised exercise training at the hospital gym for approximately 12-16 weeks; 2) nutritional consultation and diet optimization and supplementation if needed; 3) individual or group-based psychological support.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Non-resectable tumours
* Patients who refuse either surgical resection or neoadjuvant therapy
18 Years
ALL
No
Sponsors
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Fundació Sanitaria de Mollet
UNKNOWN
Hospital General de Granollers
UNKNOWN
Consorci Hospitalari de Vic
OTHER
CHU de Rouen - Accueil
OTHER
Hospital Clinic of Barcelona
OTHER
Responsible Party
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Graciela Martinez-Palli
Senior Consultant
Locations
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Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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Raquel Sebio, PhD
Role: primary
References
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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.
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.
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.
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.
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.
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.
Chen YX, Sebio-Garcia R, Arguis MJ, Reguart N, Arcocha A, Navarro A, Navarro-Ripoll R, Boujibar F, Munoz-Borrajo S, Boada M, Urena A, Guirao A, Siso M, Cardena-Gutierrez A, Perez-Garcia R, Bello I, Martinez-Palli G. Multimodal prehabilitation to prevent loss of cardiorespiratory fitness in patients with locally advanced lung cancer undergoing chemoimmunotherapy: protocol for a non-randomized multicentre study. Transl Lung Cancer Res. 2025 Sep 30;14(9):4057-4067. doi: 10.21037/tlcr-2025-311. Epub 2025 Sep 28.
Other Identifiers
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HCB-TNA-2022
Identifier Type: -
Identifier Source: org_study_id
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