Multimodal Prehabilitation in Patients with Lung Cancer Undergoing Neoadjuvant Therapy

NCT05636969 | Recruiting

• 1 other identifier: HCB-TNA-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Neoadjuvant therapy (NAT) with chemoimmunotherapy is currently indicated for patients with locoregional advanced non-small cell lung cancer (NSCLC) prior to resection surgery, but literature has suggested that this is associated with decreased pulmonary function and potentially cardiorespiratory fitness, leading to increased risk of postoperative complications. In this study, we aimed to: 1) compare the effects of NAT on cardiorespiratory fitness (VO2peak) and lung function (DLCO, FEV1 and FVC) in patients with locoregional lung cancer undergoing prehabilitation before lung resection surgery. Secondary objectives included:

1. 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. 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. 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. 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. 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.

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Changes in diffusion capacity of carbon monoxide (DLCO)

  2 weeks post-neoadjuvant therapy

• Changes in submaximal cardiorespiratory fitness assessed with a cardiopulmonary exercise test

  2 weeks post-neoadjuvant therapy

• Changes in ventilatory efficiency (VE/VCO2 slope) assessed during a cardiopulmonary exercise test

  2 weeks post-neoadjuvant therapy

• Changes in pulmonary function (FEV1)

  2 weeks post-neoadjuvant therapy

• Changes in pulmonary function (FVC)

  2 weeks post-neoadjuvant therapy

Study Arms (2)

Prehabilitation

EXPERIMENTAL

Patients in this group will attend a supervised multimodal prehabilitation programme

Behavioral: Multimodal prehabilitation

Control

NO INTERVENTION

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

Interventions

Multimodal prehabilitation BEHAVIORAL

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.

Prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with diagnosed non-small celll lung cancer (NSCLC) undergoing neoadjuvant therapy before lung resection surgery

You may not qualify if:

• Physical impairments that prevent patients to perform a CardioPulmonary Exercise Test
• Non-resectable tumours
• Patients who refuse either surgical resection or neoadjuvant therapy

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Fundació Sanitaria de Mollet: collaborator
• Hospital General de Granollers: collaborator
• Consorci Hospitalari de Vic: collaborator
• CHU de Rouen - Accueil: collaborator

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

RECRUITING

Related Publications (9)

• 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.

  PMID: 31638692 BACKGROUND

• 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.

  PMID: 35379545 BACKGROUND

• 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.

  PMID: 35086669 BACKGROUND

• 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.

  PMID: 24731268 BACKGROUND

• 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.

  PMID: 27138851 BACKGROUND

• 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.

  PMID: 23756434 BACKGROUND

• 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.

  PMID: 36170564 BACKGROUND

• 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.

  PMID: 34725764 BACKGROUND

• 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.

  PMID: 41133003 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Raquel Sebio, PhD

CONTACT

+34634787194; sebio@clinic.cat

Graciela Martínez-Pallí, PhD

CONTACT

932275400; gmartin@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blinded to whether patients receiving prehabilitation or not for some outcome measures (complications, neoadjuvant-related outcomes). Researchers conducting analyses will be blinded to patient allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: December 5, 2022
• Study Start: June 10, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 19, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)