Non Small Cell Lung CancerNCT07489391
Concomitant Use of Radiotherapy and Integrated Exercise - Lung Cancer
A study testing Multimodal exercise in people with Non Small Cell Lung Cancer and Radiation Therapy Patient, run by University of Deusto at 2 sites in Spain.
Trial summary
Study objective and procedures The objective of CURIE-LC is to evaluate the feasibility (i.e., whether it is possible and safe) of carrying out a comprehensive exercise program during combined radiotherapy and chemotherapy in patients with lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Radiation Therapy Patient, Stage II/III
- What is being tested?
- Multimodal exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesSpain
- Study dates
- Apr 2026to Dec 2026
- 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
- Histological diagnosis of non-small cell lung cancer (NSCLC) at stage II-III (locally advanced), unresectable/inoperable.
- Candidate for radical radiotherapy with concomitant chemotherapy, with or without maintenance Durvalumab.
- ECOG performance status ≤2 (or Karnofsky index ≥60).
- Ability to communicate adequately with the research team and to complete questionnaires and functional tests.
- Signed written informed consent after receiving detailed information about the study.
Who cannot join
- Decompensated cardiorespiratory comorbidities that contraindicate moderate-intensity physical exercise:
- New York Heart Association (NYHA) class III-IV congestive heart failure or unstable angina.
- Recent myocardial infarction (<6 months) or uncontrolled arrhythmias.
- Very severe chronic obstructive pulmonary disease (COPD) GOLD IV with recent exacerbations, permanent home oxygen therapy, or severe pulmonary hypertension.
- Severe physical or neurological limitations that prevent exercise.
- Absolute medical contraindications to inspiratory muscle training: unresolved pneumothorax, recent thoracic surgery (<4 weeks), or active hemoptysis.
- Refusal or inability to understand/follow the program instructions (e.g., severe cognitive impairment, insurmountable language barrier).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Clinic de Barcelona
Barcelona, Catalonia, 08036
Raquel Sebio, 0034 932275400, jurgi.zulaika@deusto.es
- Recruiting
Hospital Universitario de Navarra
Pamplona, Navarre, 31008
Núria Bultó, 0034 848422222, nuria.bulto.boque@navarra.es
About this study
Official title: Effect of an Integrated Exercise Program Concomitant With Radiotherapy on Functional Capacity in Patients With Lung Cancer
Study objective and procedures
The objective of CURIE-LC is to evaluate the feasibility (i.e., whether it is possible and safe) of carrying out a comprehensive exercise program during combined radiotherapy and chemotherapy in patients with lung cancer. The study will assess whether patients can adhere to the exercise program while receiving oncologic treatment and will explore its effects on physical fitness and quality of life.
Read more
What does participation involve?
If participants choose to take part, they will join a supervised exercise program conducted throughout the chemoradiotherapy treatment. The program includes three main components, tailored to the individuals' abilities:
Inspiratory breathing exercise: training with a specialized device to strengthen the breathing muscles and improve lung capacity.
Aerobic exercise: moderate-intensity aerobic activity (e.g., treadmill walking or stationary cycling) several days per week to improve endurance and cardiovascular health.
Strength training: muscle-strengthening exercises (e.g., light weights or resistance bands) twice per week to maintain or increase arm and leg strength.
A physiotherapist or other trained professional will guide the participant at all times to ensure exercises are performed safely and appropriately. Sessions will last approximately 20 to 60 minutes and will be coordinated with the radiotherapy/chemotherapy schedule so as not to interfere with the treatment.
In addition to the exercise sessions, participants will undergo physical assessments and complete questionnaires at several time points. Before starting and at the end of the program, the investigagtors will measure functional capacity using the 6-minute walk test (6MWT) and assess respiratory muscle strength using maximal inspiratory and expiratory pressures (PImax and PEmax). Handgrip strength will also be measured. Participants will complete questionnaires about health status, fatigue, mood, and quality of life. These evaluations will help determine the impact of exercise during treatment.
The exercise program will last for the duration of the treatment, approximately 7 to 9 weeks, with a short-term follow-up after treatment ends. Overall, participation involves attending the scheduled weekly exercise sessions during treatment, plus several evaluation visits (before, during, at the end of the program, and a few months later). Exact timing and frequency will be explained and planned according to the individual situation, aiming to minimize disruption to daily routine.
- Being tested
- Multimodal exercise
- Keywords
- Lung Cancer, Exercise, Radiochemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal exerciseOther
Also called Aerobic exercise, Resistance training, Breathing exercise
The intervention consists of 7-9 weeks of multimodal exercise training prior to radiotherapy session.
- Aerobic exercise: 40' of moderate intensity on stationary bike or treadmill; 3 days/week.
- Resistance training: 16 sets of 8 reps. at 80% of 1RM; 1' rest between sets; 2 days/week.
- Inspiratory Muscle Training: 2x30 breathing cycles at 30% of PIMax + 5% weekly improvement; 4 days unsupervised + 1 supervised session.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal exercise program during chemoradiotherapy | Experimental | Patients will start 2 weeks prior to radiotherapy treatment. The intervention will consist of 3 days of aerobic exercise, 2 days of resistance training and 5 days of unsupervised inspiratory muscle training during 9 weeks. Receives: Other: Multimodal exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the exercise program
Adherence will be primarily measured as compliance with the prescribed exercise dose, not only attendance. Each participant will complete a structured diary (daily log) that will record:
- IMT: minutes and sets completed.
- Aerobic exercise: minutes, modality, and perceived intensity using the modified Borg scale.
- Strength exercise: exercises/sets/repetitions completed and load (or perceived effort).
During supervised sessions, the physiotherapist will confirm compliance; during unsupervised sessions, the diary will be reviewed weekly.
Adherence will be calculated using the average of components weighted by the prescribed dose, and the program will be considered feasible if:
- the overall mean adherence is ≥70% of the prescribed dose; and
- ≥70% of participants achieve ≥70% adherence.
Measured: From enrollment to the end of treatment at 7-9 weeks
Patient Reported Experience Measures
Evaluates the patient's satisfaction with and acceptance of the program.
Measurement instrument: An ad hoc-designed satisfaction survey, with standardized items on a Likert scale (e.g., overall satisfaction, perceived usefulness, session comfort, likelihood of recommending the experience, etc.).
Procedure: The satisfaction survey will be administered at the end of the intervention. Patients' responses regarding different organizational and perceived aspects of the program will be collected; these responses will be transformed into quantitative scores (0-10 or 1-5 depending on the Likert scale used) and/or into the proportion of positive responses. This PREM will provide information on the acceptability of the intervention.
Measured: At the end of intervention at 9 weeks
Adverse events
Refers to the incidence of clinical adverse effects related to oncological treatment or to the performance of exercise.
Measurement instrument: Standardized toxicity recording according to CTCAE v5.0 criteria (Common Terminology Criteria for Adverse Events, version 5.0).
Procedure: Throughout the study, adverse events will be systematically monitored and documented, distinguishing those associated with radio/chemotherapy treatment from those potentially attributable to exercise. In particular, the following will be monitored: acute pneumonitis ≥ grade 2, radiation-induced esophagitis, weight loss ≥5% from baseline, unplanned hospitalizations, and hematological toxicities (e.g., neutropenia, anemia, or thrombocytopenia ≥ grade 2).
Each event will be evaluated by the radiation oncologist using the CTCAE v5.0 scale to assign a severity grade. The exercise program will be considered safe if no serious exercise-related adverse events are observed.
Measured: From start of intervention through 3 months after completion of the intervention (approximately 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Deusto
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Hospital of Navarra
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07489391
- Sponsor's protocol ID
- CURIE-LC Pilot
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Integrated Exercise Program Concomitant With Radiotherapy on Functional Capacity in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT07489391
- Acronym / sponsor ID
- CURIE-LC Pilot
- Keywords
- Lung Cancer, Exercise, Radiochemotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of DeustoUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Hospital of Navarra
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 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.
Study objective and procedures
The objective of CURIE-LC is to evaluate the feasibility (i.e., whether it is possible and safe) of carrying out a comprehensive exercise program during combined radiotherapy and chemotherapy in patients with lung cancer. The study will assess whether patients can adhere to the exercise program while receiving oncologic treatment and will explore its effects on physical fitness and quality of life.
What does participation involve?
If participants choose to take part, they will join a supervised exercise program conducted throughout the chemoradiotherapy treatment. The program includes three main components, tailored to the individuals' abilities:
Inspiratory breathing exercise: training with a specialized device to strengthen the breathing muscles and improve lung capacity.
Aerobic exercise: moderate-intensity aerobic activity (e.g., treadmill walking or stationary cycling) several days per week to improve endurance and cardiovascular health.
Strength training: muscle-strengthening exercises (e.g., light weights or resistance bands) twice per week to maintain or increase arm and leg strength.
A physiotherapist or other trained professional will guide the participant at all times to ensure exercises are performed safely and appropriately. Sessions will last approximately 20 to 60 minutes and will be coordinated with the radiotherapy/chemotherapy schedule so as not to interfere with the treatment.
In addition to the exercise sessions, participants will undergo physical assessments and complete questionnaires at several time points. Before starting and at the end of the program, the investigagtors will measure functional capacity using the 6-minute walk test (6MWT) and assess respiratory muscle strength using maximal inspiratory and expiratory pressures (PImax and PEmax). Handgrip strength will also be measured. Participants will complete questionnaires about health status, fatigue, mood, and quality of life. These evaluations will help determine the impact of exercise during treatment.
The exercise program will last for the duration of the treatment, approximately 7 to 9 weeks, with a short-term follow-up after treatment ends. Overall, participation involves attending the scheduled weekly exercise sessions during treatment, plus several evaluation visits (before, during, at the end of the program, and a few months later). Exact timing and frequency will be explained and planned according to the individual situation, aiming to minimize disruption to daily routine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multimodal exercise program during chemoradiotherapy | Experimental | Other: Multimodal exercisePatients will start 2 weeks prior to radiotherapy treatment. The intervention will consist of 3 days of aerobic exercise, 2 days of resistance training and 5 days of unsupervised inspiratory muscle training during 9 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histological diagnosis of non-small cell lung cancer (NSCLC) at stage II-III (locally advanced), unresectable/inoperable.
- Candidate for radical radiotherapy with concomitant chemotherapy, with or without maintenance Durvalumab.
- ECOG performance status ≤2 (or Karnofsky index ≥60).
- Ability to communicate adequately with the research team and to complete questionnaires and functional tests.
- Signed written informed consent after receiving detailed information about the study.
Key exclusion criteria (7 listed)
- Decompensated cardiorespiratory comorbidities that contraindicate moderate-intensity physical exercise:
- Severe physical or neurological limitations that prevent exercise.
- Absolute medical contraindications to inspiratory muscle training: unresolved pneumothorax, recent thoracic surgery (<4 weeks), or active hemoptysis.
- Refusal or inability to understand/follow the program instructions (e.g., severe cognitive impairment, insurmountable language barrier).
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 exerciseAlso: Aerobic exercise, Resistance training, Breathing exerciseThe intervention consists of 7-9 weeks of multimodal exercise training prior to radiotherapy session. 1. Aerobic exercise: 40' of moderate intensity on stationary bike or treadmill; 3 days/week. 2. Resistance training: 16 sets of 8 reps. at 80% of 1RM; 1' rest between sets; 2 days/week. 3. Inspiratory Muscle Training: 2x30 breathing cycles at 30% of PIMax + 5% weekly improvement; 4 days unsupervised + 1 supervised session. | Other | Multimodal exercise program during chemoradiotherapy |
Primary outcome
Adherence to the exercise program
Time frame: From enrollment to the end of treatment at 7-9 weeks
Adherence will be primarily measured as compliance with the prescribed exercise dose, not only attendance. Each participant will complete a structured diary (daily log) that will record: * IMT: minutes and sets completed. * Aerobic exercise: minutes, modality, and perceived intensity using the modified Borg scale. * Strength exercise: exercises/sets/repetitions completed and load (or perceived effort). During supervised sessions, the physiotherapist will confirm compliance; during unsupervised sessions, the diary will be reviewed weekly. Adherence will be calculated using the average of components weighted by the prescribed dose, and the program will be considered feasible if: 1. the overall mean adherence is ≥70% of the prescribed dose; and 2. ≥70% of participants achieve ≥70% adherence.
Patient Reported Experience Measures
Time frame: At the end of intervention at 9 weeks
Evaluates the patient's satisfaction with and acceptance of the program. Measurement instrument: An ad hoc-designed satisfaction survey, with standardized items on a Likert scale (e.g., overall satisfaction, perceived usefulness, session comfort, likelihood of recommending the experience, etc.). Procedure: The satisfaction survey will be administered at the end of the intervention. Patients' responses regarding different organizational and perceived aspects of the program will be collected; these responses will be transformed into quantitative scores (0-10 or 1-5 depending on the Likert scale used) and/or into the proportion of positive responses. This PREM will provide information on the acceptability of the intervention.
Adverse events
Time frame: From start of intervention through 3 months after completion of the intervention (approximately 5 months)
Refers to the incidence of clinical adverse effects related to oncological treatment or to the performance of exercise. Measurement instrument: Standardized toxicity recording according to CTCAE v5.0 criteria (Common Terminology Criteria for Adverse Events, version 5.0). Procedure: Throughout the study, adverse events will be systematically monitored and documented, distinguishing those associated with radio/chemotherapy treatment from those potentially attributable to exercise. In particular, the following will be monitored: acute pneumonitis ≥ grade 2, radiation-induced esophagitis, weight loss ≥5% from baseline, unplanned hospitalizations, and hematological toxicities (e.g., neutropenia, anemia, or thrombocytopenia ≥ grade 2). Each event will be evaluated by the radiation oncologist using the CTCAE v5.0 scale to assign a severity grade. The exercise program will be considered safe if no serious exercise-related adverse events are observed.
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 6 May 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal exercise in people with Non Small Cell Lung Cancer and Radiation Therapy Patient, run by University of Deusto at 2 sites 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 5 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: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Jurgi Zulaika (+34 943 32 66 00 ext. 5190, jurgi.zulaika@deusto.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to the exercise program (time frame: From enrollment to the end of treatment at 7-9 weeks). The study lists 3 primary outcomes in all. 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 6 May 2026.