Locally Advanced Non-small Cell Lung Cancer (NSCLC)PREHABNCT07479407
Effect of Pre-operative Exercise Training on Cardiorespiratory Fitness in Patients With Locally Advanced Non-small Cell Lung Cancer Undergoing Induction Chemo-immunotherapy Followed by Surgery - a Randomized Controlled Study
A study testing Preoperative Exercise Training in people with Locally Advanced Non-small Cell Lung Cancer (NSCLC), run by Hôpital du Valais at 3 sites in Switzerland.
Trial summary
The PREHAB study focuses on patients with locally advanced non-small cell lung cancer (NSCLC) undergoing neoadjuvant chemotherapy and/or immunotherapy prior to surgical resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Non-small Cell Lung Cancer (NSCLC)
- What is being tested?
- Preoperative Exercise Training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Apr 2026to Apr 2029
- 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
- Age ≥18 years.
- Confirmed diagnosis of stage IIB, IIIA, IIIB or oligo-metastatic stage IV NSCLC.
- Planned induction therapy with either chemotherapy, immunotherapy or a combination of immuno-chemotherapy followed by an anatomical pulmonary resection.
- Absence of musculoskeletal conditions preventing safe physical exercise.
- Absence of any history of uncontrolled or unstable cardiac disease.
- Agreement to participate in the study by signing the study specific informed consent form.
Who cannot join
- Pregnancy (confirmed by a test if applicable).
- Induction therapy already initiated.
- Inability to walk independently.
- Lack of decision-making capacity.
- Oxygen-dependency before the initiation of the induction protocol.
- No capacity for discernment.
- Does not speak French.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, 1205
Benoît Bédat, PD, +41795904475, benoit.bedat@hug.ch
Benoît Bédat, PD
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1005
Michel Gonzalez, Professor, +41795563820, michel.gonzalez@chuv.ch
Michel Gonzalez, Professor
Hôpital de Sion
Sion, Valais, 1951
Céline Forster, MD, +41276038944, celine.forster@hopitalvs.ch
Céline Forster, MD
About this study
The PREHAB study focuses on patients with locally advanced non-small cell lung cancer (NSCLC) undergoing neoadjuvant chemotherapy and/or immunotherapy prior to surgical resection. These systemic treatments frequently impair patients' physiological reserve, reduce physical fitness, and may occasionally lead to cancellation of surgery. Surgery itself carries a substantial risk of cardiorespiratory complications and long-term functional decline.
The primary objective of this study is to determine whether a supervised exercise program, initiated concomitantly with systemic therapy and continued until surgery, can improve cardiorespiratory fitness, surgical tolerance, and postoperative outcomes.
Read more
A total of 74 patients will be randomly assigned to one of two groups: an "intervention" group participating in three weekly sessions of supervised endurance and resistance training for 12 to 16 weeks under the guidance of a physiotherapist, and a "control" group receiving usual care without a structured exercise program.
The primary endpoint will be peak oxygen uptake (VO₂peak). Secondary outcomes will include postoperative complication rates, length of hospital stay, pulmonary function, skeletal muscle mass, and quality of life.
Intervention-related risks, primarily falls or overexertion, will be mitigated through professional supervision. This multicenter study, with recruitment scheduled to begin in 2026, is expected to provide robust evidence regarding the effectiveness of targeted exercise training in improving preoperative fitness and postoperative recovery in patients with locally advanced NSCLC.
Read the detailed description
The PREHAB study is a prospective, multicenter, randomized controlled trial designed to evaluate the efficacy of a structured, supervised prehabilitation program in patients with locally advanced non-small cell lung cancer (NSCLC) undergoing neoadjuvant chemotherapy and/or immunotherapy prior to surgical resection.
Patients with stage III NSCLC increasingly receive multimodal treatment strategies combining systemic therapy followed by surgery. While neoadjuvant chemotherapy and immunotherapy have improved oncologic outcomes, these treatments frequently induce treatment-related deconditioning, sarcopenia, fatigue, and reduced cardiopulmonary reserve. Consequently, a subset of patients experiences functional decline significant enough to compromise surgical eligibility. Moreover, thoracic surgery itself is associated with substantial postoperative morbidity, particularly cardiorespiratory complications, and long-term impairment in physical performance.
The PREHAB trial is based on the hypothesis that early, structured, and supervised exercise training initiated concomitantly with systemic therapy and continued until surgery can mitigate treatment-induced physiological deterioration, preserve or enhance cardiorespiratory fitness, and ultimately improve perioperative and postoperative outcomes.
A total of 74 patients will be randomized in a 1:1 ratio to either:
- Intervention group: participation in a 12-16 week supervised exercise program consisting of three weekly sessions combining endurance and resistance training, delivered by trained physiotherapists.
- Control group: standard oncologic care without a structured exercise intervention.
The primary endpoint is change in peak oxygen uptake (VO₂peak), measured by cardiopulmonary exercise testing, as an objective marker of cardiorespiratory fitness and surgical resilience.
Secondary endpoints include:
- Postoperative complication rates
- Length of hospital stay
- Pulmonary function parameters
- Skeletal muscle mass
- Health-related quality of life
Safety considerations focus primarily on the risk of falls and overexertion, both minimized through professional supervision and individualized exercise prescription.
By targeting the vulnerable neoadjuvant window - when patients are exposed to systemic therapy but have not yet undergone surgery - PREHAB aims to redefine perioperative optimization in locally advanced NSCLC. If positive, this trial could provide high-level evidence supporting the integration of structured exercise prehabilitation into standard multimodal lung cancer care pathways.
- Being tested
- Preoperative Exercise Training
- Keywords
- Non-small cell lung cancer, Locally advanced NSCLC, Neoadjuvant therapy, Immunotherapy, Prehabilitation, Exercise training, VO2peak, Cardiopulmonary exercise testing, Thoracic surgery, Postoperative complications
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Exercise TrainingProcedure or surgery
The intervention consists of a structured, supervised pre-operative exercise training program initiated concomitantly with induction chemo- and/or immunotherapy and continued until 24-72 hours prior to surgery. The program is delivered in an outpatient setting and supervised by trained physiotherapists following a standardized protocol across study sites.
Participants randomized to the intervention group will complete three sessions per week, each lasting 45-60 minutes, for a total duration of 12 to 16 weeks depending on the length of induction therapy. Each session combines aerobic and resistance training components. Aerobic exercise is performed on a cycle ergometer at an initial intensity of approximately 60% of baseline VO₂peak, with progressive increases in duration and intensity aiming for 30-40 minutes at a Borg perceived exertion score of 4-6. Resistance training targets major upper and lower muscle groups using functional exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group: participation in a 12-16 week supervised exercise program consisting of three weekly sessions combining endurance and resistance training, delivered by trained physiotherapists. Receives: Procedure: Preoperative Exercise Training |
| Control | No intervention | Control group: standard oncologic care without a structured exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak oxygen uptake (VO₂peak) from baseline to pre-surgery
The primary endpoint is peak oxygen uptake (VO₂peak), measured by standardized cardiopulmonary exercise testing (CPET). VO₂peak reflects the integrative capacity of the cardiovascular, pulmonary, and muscular systems during maximal exertion and is a validated indicator of surgical fitness and perioperative risk. VO₂peak will be assessed at baseline (before induction therapy) and repeated 24-72 hours prior to surgery. The primary analysis will compare pre-surgery VO₂peak between groups using ANCOVA adjusted for baseline VO₂peak.
Measured: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.
Secondary outcomes (7)
Change in ventilatory efficiency (VE/VCO₂ slope) from baseline to pre-surgery
VE/VCO₂ slope measured during CPET as an index of ventilatory efficiency and ventilation-perfusion matching. Elevated values are associated with increased perioperative risk. The outcome is the between-group difference at pre-surgery adjusted for baseline value.
Measured: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.
Change in 6-minute walk distance from baseline to pre-surgery
Distance walked during the standardized 6-minute walk test (6MWT) performed indoors on a 30-meter corridor according to established guidelines. The outcome is the between-group difference in walking distance at pre-surgery adjusted for baseline.
Measured: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.
Rate of 30-day postoperative cardiopulmonary complications
Proportion of patients experiencing at least one predefined cardiopulmonary complication within 30 days after surgery, including atrial fibrillation, pneumonia, prolonged air leak, pulmonary embolism, ARDS, pneumothorax, or myocardial infarction. Between-group comparison.
Measured: From surgery to 30 days postoperatively.
Length of postoperative hospital stay
Number of days from the date of surgery to hospital discharge. Comparison of mean length of stay between intervention and control groups.
Measured: From surgery until hospital discharge.
Change in health-related quality of life (EORTC QLQ-C30 global score)
Health-related quality of life assessed using the EORTC QLQ-C30 questionnaire (version 3.0). The primary QoL endpoint is the global health status/quality of life score. Between-group comparison of change from baseline to pre-surgery.
Measured: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.
Change in skeletal muscle cross-sectional area on CT imaging
Skeletal muscle cross-sectional area and radiodensity measured on CT scans at the L3 vertebral level. Change from baseline to pre-surgery compared between groups as an index of sarcopenia and muscle quality.
Measured: From baseline to 4-6 weeks prior to surgery at approximately 12 weeks.
Change in pulmonary function (FEV1 and DLCO) from baseline to pre-surgery
Forced expiratory volume in 1 second (FEV1) and diffusing capacity for carbon monoxide (DLCO) measured using standardized pulmonary function testing. Between-group comparison of change from baseline to pre-surgery.
Measured: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Non-small Cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital du Valais
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479407
- Sponsor's protocol ID
- Preoperative exercise training
- Acronym
- PREHAB
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) underlying the results reported in the publication of the primary and secondary outcomes will be shared. This will include de-identified individual-level data for baseline characteristics, group allocation, primary outcome data (VO₂peak at baseline and pre-surgery), secondary outcome measures (VE/VCO₂ slope, 6-minute walk distance, postoperative complications, length of stay, pulmonary function, skeletal muscle mass, and quality of life scores), and adherence data. All shared data will be fully de-identified in accordance with applicable data protection regulations. The study protocol, statistical analysis plan, and data dictionary will also be made available.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-operative Exercise Training on Cardiorespiratory Fitness in Patients With Locally Advanced Non-small Cell Lung Cancer Undergoing Induction Chemo-immunotherapy Followed by Surgery - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07479407
- Acronym / sponsor ID
- PREHAB / Preoperative exercise training
- Keywords
- Non-small cell lung cancer, Locally advanced NSCLC, Neoadjuvant therapy, Immunotherapy, Prehabilitation, Exercise training, VO2peak, Cardiopulmonary exercise testing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Hôpital du ValaisUniversity, hospital or other
- Collaborators
- University Hospital, Geneva, Centre Hospitalier Universitaire Vaudois
- Study start
- Apr 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 18 Mar 2026 (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.
The PREHAB study focuses on patients with locally advanced non-small cell lung cancer (NSCLC) undergoing neoadjuvant chemotherapy and/or immunotherapy prior to surgical resection. These systemic treatments frequently impair patients' physiological reserve, reduce physical fitness, and may occasionally lead to cancellation of surgery. Surgery itself carries a substantial risk of cardiorespiratory complications and long-term functional decline.
The primary objective of this study is to determine whether a supervised exercise program, initiated concomitantly with systemic therapy and continued until surgery, can improve cardiorespiratory fitness, surgical tolerance, and postoperative outcomes.
A total of 74 patients will be randomly assigned to one of two groups: an "intervention" group participating in three weekly sessions of supervised endurance and resistance training for 12 to 16 weeks under the guidance of a physiotherapist, and a "control" group receiving usual care without a structured exercise program.
The primary endpoint will be peak oxygen uptake (VO₂peak). Secondary outcomes will include postoperative complication rates, length of hospital stay, pulmonary function, skeletal muscle mass, and quality of life.
Intervention-related risks, primarily falls or overexertion, will be mitigated through professional supervision. This multicenter study, with recruitment scheduled to begin in 2026, is expected to provide robust evidence regarding the effectiveness of targeted exercise training in improving preoperative fitness and postoperative recovery in patients with locally advanced NSCLC.
Detailed description
The PREHAB study is a prospective, multicenter, randomized controlled trial designed to evaluate the efficacy of a structured, supervised prehabilitation program in patients with locally advanced non-small cell lung cancer (NSCLC) undergoing neoadjuvant chemotherapy and/or immunotherapy prior to surgical resection.
Patients with stage III NSCLC increasingly receive multimodal treatment strategies combining systemic therapy followed by surgery. While neoadjuvant chemotherapy and immunotherapy have improved oncologic outcomes, these treatments frequently induce treatment-related deconditioning, sarcopenia, fatigue, and reduced cardiopulmonary reserve. Consequently, a subset of patients experiences functional decline significant enough to compromise surgical eligibility. Moreover, thoracic surgery itself is associated with substantial postoperative morbidity, particularly cardiorespiratory complications, and long-term impairment in physical performance.
The PREHAB trial is based on the hypothesis that early, structured, and supervised exercise training initiated concomitantly with systemic therapy and continued until surgery can mitigate treatment-induced physiological deterioration, preserve or enhance cardiorespiratory fitness, and ultimately improve perioperative and postoperative outcomes.
A total of 74 patients will be randomized in a 1:1 ratio to either:
- Intervention group: participation in a 12-16 week supervised exercise program consisting of three weekly sessions combining endurance and resistance training, delivered by trained physiotherapists.
- Control group: standard oncologic care without a structured exercise intervention.
The primary endpoint is change in peak oxygen uptake (VO₂peak), measured by cardiopulmonary exercise testing, as an objective marker of cardiorespiratory fitness and surgical resilience.
Secondary endpoints include:
- Postoperative complication rates
- Length of hospital stay
- Pulmonary function parameters
- Skeletal muscle mass
- Health-related quality of life
Safety considerations focus primarily on the risk of falls and overexertion, both minimized through professional supervision and individualized exercise prescription.
By targeting the vulnerable neoadjuvant window - when patients are exposed to systemic therapy but have not yet undergone surgery - PREHAB aims to redefine perioperative optimization in locally advanced NSCLC. If positive, this trial could provide high-level evidence supporting the integration of structured exercise prehabilitation into standard multimodal lung cancer care pathways.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Preoperative Exercise TrainingIntervention group: participation in a 12-16 week supervised exercise program consisting of three weekly sessions combining endurance and resistance training, delivered by trained physiotherapists. |
| Control | No intervention | –Control group: standard oncologic care without a structured exercise intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years.
- Confirmed diagnosis of stage IIB, IIIA, IIIB or oligo-metastatic stage IV NSCLC.
- Planned induction therapy with either chemotherapy, immunotherapy or a combination of immuno-chemotherapy followed by an anatomical pulmonary resection.
- Absence of musculoskeletal conditions preventing safe physical exercise.
- Absence of any history of uncontrolled or unstable cardiac disease.
Key exclusion criteria (7 listed)
- Pregnancy (confirmed by a test if applicable).
- Induction therapy already initiated.
- Inability to walk independently.
- Lack of decision-making capacity.
- Oxygen-dependency before the initiation of the induction protocol.
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 |
|---|---|---|
| Preoperative Exercise TrainingThe intervention consists of a structured, supervised pre-operative exercise training program initiated concomitantly with induction chemo- and/or immunotherapy and continued until 24-72 hours prior to surgery. The program is delivered in an outpatient setting and supervised by trained physiotherapists following a standardized protocol across study sites. Participants randomized to the intervention group will complete three sessions per week, each lasting 45-60 minutes, for a total duration of 12 to 16 weeks depending on the length of induction therapy. Each session combines aerobic and resistance training components. Aerobic exercise is performed on a cycle ergometer at an initial intensity of approximately 60% of baseline VO₂peak, with progressive increases in duration and intensity aiming for 30-40 minutes at a Borg perceived exertion score of 4-6. Resistance training targets major upper and lower muscle groups using functional exercises. | Procedure or surgery | Intervention |
Primary outcome
Change in peak oxygen uptake (VO₂peak) from baseline to pre-surgery
Time frame: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.
The primary endpoint is peak oxygen uptake (VO₂peak), measured by standardized cardiopulmonary exercise testing (CPET). VO₂peak reflects the integrative capacity of the cardiovascular, pulmonary, and muscular systems during maximal exertion and is a validated indicator of surgical fitness and perioperative risk. VO₂peak will be assessed at baseline (before induction therapy) and repeated 24-72 hours prior to surgery. The primary analysis will compare pre-surgery VO₂peak between groups using ANCOVA adjusted for baseline VO₂peak.
7 secondary outcomes
Change in ventilatory efficiency (VE/VCO₂ slope) from baseline to pre-surgery
Time frame: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.
Change in 6-minute walk distance from baseline to pre-surgery
Time frame: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.
Rate of 30-day postoperative cardiopulmonary complications
Time frame: From surgery to 30 days postoperatively.
Length of postoperative hospital stay
Time frame: From surgery until hospital discharge.
Change in health-related quality of life (EORTC QLQ-C30 global score)
Time frame: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.
Change in skeletal muscle cross-sectional area on CT imaging
Time frame: From baseline to 4-6 weeks prior to surgery at approximately 12 weeks.
Change in pulmonary function (FEV1 and DLCO) from baseline to pre-surgery
Time frame: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.
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 18 Mar 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) underlying the results reported in the publication of the primary and secondary outcomes will be shared. This will include de-identified individual-level data for baseline characteristics, group allocation, primary outcome data (VO₂peak at baseline and pre-surgery), secondary outcome measures (VE/VCO₂ slope, 6-minute walk distance, postoperative complications, length of stay, pulmonary function, skeletal muscle mass, and quality of life scores), and adherence data. All shared data will be fully de-identified in accordance with applicable data protection regulations. The study protocol, statistical analysis plan, and data dictionary will also be made available.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Exercise Training in people with Locally Advanced Non-small Cell Lung Cancer (NSCLC), run by Hôpital du Valais at 3 sites in Switzerland.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak oxygen uptake (VO₂peak) from baseline to pre-surgery (time frame: From baseline to 24-72 hours prior to surgery at approximately 12-16 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Mar 2026.