protocolSection identificationModule nctId: NCT06374160, orgStudyIdInfo id: 70115371, briefTitle: Exercise in Patients With Advanced Non-small Cell Lung Cancer, acronym: BREATH, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-08-31, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: University Hospital, Essen, class: OTHER, collaborators name: German Cancer Aid, descriptionModule briefSummary: 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., conditionsModule conditions: Advanced Lung Carcinoma, conditions: First Line Treatment, conditions: Second Line Treatment, conditions: NSCLC Stage IV, conditions: NSCLC Stage IIIB, conditions: Palliative Treatment, conditions: NSCLC Stage IIIC, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: BREATH is a prospective 3-arm 2:1:1 randomized controlled trial (RCT). The first arm represents the control group, which will receive the standard treatment for the first 12 weeks (recommendations for physical activity during cancer treatment). The other two arms represent the exercise groups, one group will receive individualized endurance training and the other group a combination of individualized endurance and strength training. All arms will be treated for 12 weeks. Afterwards, the patients in the control group are randomized to one of the other two study arms and then also treated twice for 12 weeks., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 104, type: ESTIMATED, armsInterventionsModule interventions name: Exercise intervention, outcomesModule primaryOutcomes measure: Maximum oxygen uptake (VO2 peak [ml/min/kg]), secondaryOutcomes measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F), secondaryOutcomes measure: European Organisation for Research and Treatment of Cancer (EORTC QLQ C30), secondaryOutcomes measure: European Organisation for Research and Treatment of Cancer Lung cancer module (EORTC-LC13), secondaryOutcomes measure: Arterial blood pressure, secondaryOutcomes measure: Change in ECG, secondaryOutcomes measure: Adherence to exercise intervention, secondaryOutcomes measure: Drop-out rate, secondaryOutcomes measure: Recruitment rate, secondaryOutcomes measure: Serious Adverse Event/Adverse Events, secondaryOutcomes measure: Therapy response, secondaryOutcomes measure: Treatment Toxicity, secondaryOutcomes measure: Treatment scheme, secondaryOutcomes measure: NT-pro-BNP, secondaryOutcomes measure: High sensitive troponin I, secondaryOutcomes measure: Erythrocytes, secondaryOutcomes measure: Hemoglobin, secondaryOutcomes measure: Leukocytes, secondaryOutcomes measure: Lymphocytes, secondaryOutcomes measure: Neutrophils, secondaryOutcomes measure: CRP, secondaryOutcomes measure: CYRFRA 21-1, secondaryOutcomes measure: Physical function (Hypothetical One-repetition maximum), secondaryOutcomes measure: Blood gas analysis pH value, secondaryOutcomes measure: Blood gas analysis (PAO2), secondaryOutcomes measure: Blood gas analysis (SaO2), secondaryOutcomes measure: Blood gas analysis (PCO2), secondaryOutcomes measure: Blood gas analysis (BE), secondaryOutcomes measure: Blood gas analysis (HCO3), secondaryOutcomes measure: Blood gas analysis (SBCe), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: West German Cancer Center (Department of Palliative medicine and Department of Medical Oncology), University Hospital Essen, city: Essen, state: North Rhine-Westphalia, zip: 45147, country: Germany, contacts name: Mitra Tewes, PD. Dr., role: CONTACT, email: mitra.tewes@uk-essen.de, contacts name: Nico De Lazzari, M. Sc., role: CONTACT, phone: +49 201 723-82035, email: nico.delazzari@uk-essen.de, contacts name: Mitra Tewes, PD. Dr., role: PRINCIPAL_INVESTIGATOR, contacts name: Marcel Wiesweg, PD. Dr., role: SUB_INVESTIGATOR, contacts name: Miriam Götte, PD. Dr., role: SUB_INVESTIGATOR, contacts name: Eva-Maria Hüßler, Dr., role: SUB_INVESTIGATOR, contacts name: Andreas Stang, Prof. Dr., role: SUB_INVESTIGATOR, contacts name: Matthias Totzeck, Prof. Dr., role: SUB_INVESTIGATOR, geoPoint lat: 51.45657, lon: 7.01228, hasResults: False