Exercise during combined radiotherapy and chemotherapy for stage II–III non-small cell lung cancer
Effect of an Integrated Exercise Program Concomitant With Radiotherapy on Functional Capacity in Patients With Lung Cancer
This program will try a supervised exercise plan during combined radiotherapy and chemotherapy for people with stage II–III non-small cell lung cancer to see if they can follow it and whether it helps fitness and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Deusto Academic / other |
| Drugs / interventions | Durvalumab, chemotherapy |
| Locations | 2 sites (Barcelona, Catalonia and 1 other locations) |
| Trial ID | NCT07489391 on ClinicalTrials.gov |
What this trial studies
This is a feasibility study of a supervised, multimodal exercise program delivered throughout concurrent chemoradiotherapy for unresectable stage II–III non‑small cell lung cancer. The program is tailored to each patient and includes inspiratory muscle training, moderate‑intensity aerobic exercise, and strength work, with sessions supervised at the hospital. Primary outcomes focus on safety and adherence, while secondary measures explore changes in physical fitness, respiratory function, and quality of life. Participants are recruited at two Spanish centers and those with severe unstable cardiac or pulmonary comorbidities are excluded.
Who should consider this trial
Good fit: Ideal candidates are adults with unresectable stage II–III non‑small cell lung cancer who are planned for radical radiotherapy with concurrent chemotherapy, have ECOG performance status ≤2, can communicate and perform functional tests, and can provide informed consent.
Not a fit: Patients with decompensated or unstable cardiac or pulmonary disease that contraindicates moderate exercise, those on permanent home oxygen for severe COPD, or those unable to attend supervised sessions are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could help patients maintain or improve fitness, breathing strength, and quality of life during aggressive combined cancer treatment.
How similar studies have performed: Prior trials in cancer populations, including some in lung cancer, show that supervised exercise during treatment is generally safe and can improve fitness and quality of life, but integrating inspiratory muscle training specifically during concurrent chemoradiotherapy is less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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).
Where this trial is running
Barcelona, Catalonia and 1 other locations
- Hospital Clinic de Barcelona — Barcelona, Catalonia, Spain (Recruiting)
- Hospital Universitario de Navarra — Pamplona, Navarre, Spain (Recruiting)
Study contacts
- Study coordinator: Jurgi Zulaika
- Email: jurgi.zulaika@deusto.es
- Phone: +34 943 32 66 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.