Exercise in Patients With Advanced Non-small Cell Lung Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise intervention.
- Who it may be relevant to
- Registry conditions: Advanced Lung Carcinoma, First Line Treatment, Second Line Treatment, NSCLC Stage IV. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Better Symptom Control With Exercise in Patients With Advanced Non-small Cell Lung Cancer
Overview
Lung cancer is one of the most common types of cancer in Germany, with 56,839 new cases and 45,072 deaths annually. Approximately 70% of patients with non-small cell lung cancer (NSCLC) are diagnosed at an advanced stage and suffer from comorbidities and symptoms such as fatigue, tiredness, and loss of strength. The standard first-line treatment for metastatic NSCLC includes platinum-based chemoimmunotherapy followed by immunotherapy maintenance. Exercise can have positive effects on symptoms such as shortness of breath, fatigue, quality of life, and physical fitness. However, there is a lack of current scientific evidence for the effectiveness of exercise in advanced lung cancer patients. No current trial investigated exercise in advanced NSCLC receiving immunotherapy so far. The BREATH-study is a prospective 3-arm randomized controlled trial (RCT). In total, the investigators plan to recruit 104 patients. A 2:1:1 randomization will be performed with three study groups: a control group and two exercise therapy groups (strength+endurance exercise/only endurance exercise). One group receives individual endurance training and the other group a combination of individual endurance and strength training. Both treatment groups will be treated twice a week for 12 weeks. The control group will initially receive standard treatment without exercise for 12 weeks and will then be randomized into one of the other two study groups with exercise twice a week for 12 weeks. This approach allows for a sufficiently large sample for comparisons between exercise therapy and the control group, as well as between the two exercise therapy approaches. The primary aim is to investigate the impact of exercise on V02peak. Secondarily endpoints aim to investigate changes in physical function, patient related outcomes and cardiac function before and after exercise.
Interventions
- Behavioral Exercise intervention
Exercise
Primary outcome measures
- Maximum oxygen uptake (VO2 peak [ml/min/kg]) [Time frame: assessed at Baseline, after 12 weeks and 24 weeks of enrolment]
Secondary outcome measures (12)
- Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F) [Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment]
- European Organisation for Research and Treatment of Cancer (EORTC QLQ C30) [Time frame: assessed at baseline after 12 weeks and 24 weeks of enrolment]
- European Organisation for Research and Treatment of Cancer Lung cancer module (EORTC-LC13) [Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment]
- Arterial blood pressure [Time frame: assessed at Baseline, after 12 weeks and 24 weeks of enrolment]
- Change in ECG [Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment]
- Adherence to exercise intervention [Time frame: Through study completion, an average of 12 weeks]
- Drop-out rate [Time frame: Through study completion, an average of 12 weeks]
- Recruitment rate [Time frame: At Baseline]
- Serious Adverse Event/Adverse Events [Time frame: Through study completion, an average of 12 weeks]
- Therapy response [Time frame: Baseline and after 12 weeks]
- Treatment Toxicity [Time frame: assessed at baseline after 12 weeks and 24 weeks of enrolment]
- Treatment scheme [Time frame: assessed at baseline after 12 weeks and 24 weeks of enrolment]
Eligibility criteria
Inclusion criteria
- Patients with histologically confirmed non-small cell lung carcinoma in UICC stages IIIB and IV
- First- or second-line therapy (inclusion up to 28 days after the first cycle) in palliative intention
- Age ≥ 18 years
- Signed informed consent
Exclusion criteria
- Severe cardiopulmonary disease (EF<30%)
- Newly occurring or progressive uncontrolled CNS (central nervous system) metastases
- Expected life expectancy < 3 months
- Bone metastases with acute risk of fracture
- ECOG (Eastern Cooperative Oncology Group) performance status > 2
- Acute pulmonary embolism
- Acute myocardial infarction
- Requiring surgery for aortic aneurysm
- Tension pneumothorax
- Lack of proficiency in the German language
- Active infection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Germany · 1 center
- West German Cancer Center (Department of Palliative medicine and Department of Medical Onc — Essen
Publications
- De Lazzari N, Wiesweg M, Gotte M, Franco J, Mincu RI, Jager J, Huessler EM, Kuklik N, Stang A, Totzeck M, Tewes M. Improving aerobic capacity in patients with advanced non-small cell lung cancer: study protocol of the 3-armed randomized controlled BREATH trial. Trials. 2026 Jan 17;27(1):88. doi: 10.1186/s13063-025-09416-2. PMID 41546104
Identifiers
NCT: NCT06374160 · 70115371