Non Small Cell Lung CancerNCT05636969
Multimodal Prehabilitation in Patients With Lung Cancer Undergoing Neoadjuvant Therapy
A study testing Multimodal prehabilitation in people with Non Small Cell Lung Cancer, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Multimodal prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2023to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with diagnosed non-small celll lung cancer (NSCLC) undergoing neoadjuvant therapy before lung resection surgery
Who cannot join
- Physical impairments that prevent patients to perform a CardioPulmonary Exercise Test
- Non-resectable tumours
- Patients who refuse either surgical resection or neoadjuvant therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
Raquel Sebio, PhD
About this study
Official title: Effects of Multimodal Prehabilitation on Cardiorespiratory Fitness and Pulmonary Function During Neoadjuvant Therapy in Patients With Locally Advanced Lung Cancer
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:
Read more
- 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;
- 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).
- 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
- 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).
- 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).
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Multimodal prehabilitation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal prehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Patients in this group will attend a supervised multimodal prehabilitation programme Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks post-neoadjuvant therapy
Secondary outcomes (16)
Changes in diffusion capacity of carbon monoxide (DLCO)
Differences in diffusion capacity of carbon monoxide pre to post-neoadjuvant therapy
Measured: 2 weeks post-neoadjuvant therapy
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
Measured: 2 weeks post-neoadjuvant therapy
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
Measured: 2 weeks post-neoadjuvant therapy
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
Measured: 2 weeks post-neoadjuvant therapy
Changes in pulmonary function (FVC)
Differences observed in the forced ventilatory capacity (FVC) of a forced spirometry test, pre to post-neoadjuvant therapy
Measured: 2 weeks post-neoadjuvant therapy
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)
Measured: 1 week before surgery
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)
Measured: 1 week before surgery
Adherence
Number of completed exercise sessions in the prehabilitation cohort versus number of scheduled sessions
Measured: 1 week before surgery
Adverse events
Number of adverse events registered during the exercise training sessions
Measured: 1 week before surgery
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.
Measured: within 30 days of hospital discharge
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
Measured: 30 days after surgery
Chemoimmunotherapy completion rates
Chemoimmunotherapy complete dosage, treatment delays and treatment withdrawal rates will be calculated and compared in both groups
Measured: 1 week post-neoadjuvant therapy
Post-surgery functional capacity
Functional capacity assessed with the 1 min Sit-to-Stand Test which consist of counting the number of times the patient can stand up and sit back onto a chair without arm support during one minute.
Measured: Same day as dicharge from hospital
Post-NAT functional capacity
Functional capacity assessed with the 1 min Sit-to-Stand Test which consist of counting the number of times the patient can stand up and sit back onto a chair without arm support during one minute.
Measured: 2 weeks post-neoadjuvant therapy
Post-NAT mood
Anxiety and depression symptoms will be assessed with a self-administer questionnaire, the Hospital Anxiety and Depression Scale
Measured: 2 weeks post-neoadjuvant therapy
Post-NAT self-reported physical activity
Self-reported physical activity levels will be measured using a validated questionnaire, the Yale Physical Activity Survey
Measured: 2 weeks post-neoadjuvant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start10 Jun 2023
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Sanitaria de Mollet, Hospital General de Granollers, Consorci Hospitalari de Vic, CHU de Rouen - Accueil
- Responsible party
- Principal investigator, Graciela Martinez-Palli, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636969
- Sponsor's protocol ID
- HCB-TNA-2022
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2022
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31638692Cabanero 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.
PubMed 35379545Connolly 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.
PubMed 35086669Jack 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.
PubMed 24731268Sinclair 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.
PubMed 27138851Silver 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.
PubMed 23756434Granger 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.
PubMed 36170564Allen 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.
PubMed 34725764Chen 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.
PubMed 41133003
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multimodal Prehabilitation on Cardiorespiratory Fitness and Pulmonary Function During Neoadjuvant Therapy in Patients With Locally Advanced Lung Cancer
- ClinicalTrials.gov ID
- NCT05636969
- Acronym / sponsor ID
- HCB-TNA-2022
- Conditions
- Non Small Cell Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Fundació Sanitaria de Mollet, Hospital General de Granollers, Consorci Hospitalari de Vic, CHU de Rouen - Accueil
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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;
- 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).
- 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
- 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).
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Behavioral: Multimodal prehabilitationPatients in this group will attend a supervised multimodal prehabilitation programme |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with diagnosed non-small celll lung cancer (NSCLC) undergoing neoadjuvant therapy before lung resection surgery
Key exclusion criteria (3 listed)
- Physical impairments that prevent patients to perform a CardioPulmonary Exercise Test
- Non-resectable tumours
- Patients who refuse either surgical resection or neoadjuvant therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal prehabilitationThe 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. | Behavioural | Prehabilitation |
Primary outcome
Changes in cardiorespiratory fitness assessed with a cardiopulmonary exercise test
Time frame: 2 weeks post-neoadjuvant therapy
Differences in maximum oxygen consumption (VO2pic) pre to post neoadjvuant therapy during an incremental, symptom-limited test
16 secondary outcomes
Changes in diffusion capacity of carbon monoxide (DLCO)
Time frame: 2 weeks post-neoadjuvant therapy
Changes in submaximal cardiorespiratory fitness assessed with a cardiopulmonary exercise test
Time frame: 2 weeks post-neoadjuvant therapy
Changes in ventilatory efficiency (VE/VCO2 slope) assessed during a cardiopulmonary exercise test
Time frame: 2 weeks post-neoadjuvant therapy
Changes in pulmonary function (FEV1)
Time frame: 2 weeks post-neoadjuvant therapy
Changes in pulmonary function (FVC)
Time frame: 2 weeks post-neoadjuvant therapy
Feasibility (recruitment rate ) of multimodal prehabilitation
Time frame: 1 week before surgery
Feasibility (completion rate) of multimodal prehabilitation
Time frame: 1 week before surgery
Adherence
Time frame: 1 week before surgery
Adverse events
Time frame: 1 week before surgery
Postoperative Complications
Time frame: within 30 days of hospital discharge
30-Day readmissions, re-interventions and emergency room visits
Time frame: 30 days after surgery
Chemoimmunotherapy completion rates
Time frame: 1 week post-neoadjuvant therapy
Post-surgery functional capacity
Time frame: Same day as dicharge from hospital
Post-NAT functional capacity
Time frame: 2 weeks post-neoadjuvant therapy
Post-NAT mood
Time frame: 2 weeks post-neoadjuvant therapy
Post-NAT self-reported physical activity
Time frame: 2 weeks post-neoadjuvant therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 31638692Brunelli 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.
- Background: PubMed 35379545Cabanero 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.
- Background: PubMed 35086669Connolly 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.
- Background: PubMed 24731268Jack 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.
- Background: PubMed 27138851Sinclair 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.
- Background: PubMed 23756434Silver 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.
- Background: PubMed 36170564Granger 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.
- Background: PubMed 34725764Allen 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.
- Derived from this study: PubMed 41133003Chen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal prehabilitation in people with Non Small Cell Lung Cancer, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raquel Sebio, PhD (+34634787194, sebio@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cardiorespiratory fitness assessed with a cardiopulmonary exercise test (time frame: 2 weeks post-neoadjuvant therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05636969, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.