Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT06374160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exercise in Patients With Advanced Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 104}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2024-04-10', 'studyFirstSubmitQcDate': '2024-04-15', 'lastUpdatePostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum oxygen uptake (VO2 peak [ml/min/kg])', 'timeFrame': 'assessed at Baseline, after 12 weeks and 24 weeks of enrolment', 'description': 'The primary goal is to achieve an improvement in performance (VO2 peak\\[ml/min/kg\\]) from T0 (enrolment) to T1 (12 weeks) through exercise compared to the standard treatment. The one-sided alternative hypothesis of a larger improvement in the two treatment groups compared to the control group will be tested statistically as a confirmatory analysis.'}], 'secondaryOutcomes': [{'measure': 'Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F)', 'timeFrame': 'assessed at baseline, after 12 weeks and 24 weeks of enrolment', 'description': 'The FACT-F is a 13-item questionnaire to assess fatigue in cancer patients. Subscale are physical well-being, social/family well-being, emotional well-being, functional well-being and the fatigue subscale. Based on the subscale the FACIT-F trial outcome index (TOI) Score range 0-108, FACT-G total score (Score range 0-108) and FACIT-F total score (Score range 0-160) can be calculated. The higher the score, the better the Quality of Life.'}, {'measure': 'European Organisation for Research and Treatment of Cancer (EORTC QLQ C30)', 'timeFrame': 'assessed at baseline after 12 weeks and 24 weeks of enrolment', 'description': 'The EORTC QLQ Core Questionnaire is a 30-item instrument meant to assess some of the different aspects that define the quality of life of cancer patients (e.g., physical function, emotional function, symptom scales, and Quality of Life). High scores for functional scales (score 0-100) represent a high level of functioning, high scores for the global health status represent a high quality of life (score 0-100), high scores for symptom scales (score 0-100) represent a high level of symptomatology.'}, {'measure': 'European Organisation for Research and Treatment of Cancer Lung cancer module (EORTC-LC13)', 'timeFrame': 'assessed at baseline, after 12 weeks and 24 weeks of enrolment', 'description': 'The LC13 is a modular supplement to the EORTC-C30 for assessment of symptoms in clinical lung. cancer trials. The scoring range is between 0 to 100, a high score indicating a high level of symptomatology.'}, {'measure': 'Arterial blood pressure', 'timeFrame': 'assessed at Baseline, after 12 weeks and 24 weeks of enrolment', 'description': 'Change during study participation (mmHg)'}, {'measure': 'Change in ECG', 'timeFrame': 'assessed at baseline, after 12 weeks and 24 weeks of enrolment', 'description': 'Changes in 12-lead resting ECG, including PQ \\[ms\\], QRS \\[ms\\], and QT \\[ms\\] intervals'}, {'measure': 'Adherence to exercise intervention', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'The exercise physiologist monitored adherence to the supervised sessions. Based on the absolute numbers of scheduled exercise sessions, both absolute and percentage-based adherence can be calculated and compared between study arms.'}, {'measure': 'Drop-out rate', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'All withdrawals will be considered as dropouts, with reasons noted. Compare the total number of dropouts in each study arm. This provides a straightforward comparison of the raw dropout counts between groups. Also, calculate the percentage of participants who dropped out in each study arm relative to the total number of participants initially assigned to that arm. This allows for a comparison of dropout rates relative to the initial sample size and compared between study arms.'}, {'measure': 'Recruitment rate', 'timeFrame': 'At Baseline', 'description': 'The recruitment rate quantifies the speed of participant enrollment for a study.'}, {'measure': 'Serious Adverse Event/Adverse Events', 'timeFrame': 'Through study completion, an average of 12 weeks', 'description': 'Safety analyses will be based on Adverse Events (AEs), Serious Adverse Events (SAEs) after the Common Terminology Criteria for Adverse Events (CTCAE) v5.0'}, {'measure': 'Therapy response', 'timeFrame': 'Baseline and after 12 weeks', 'description': 'Therapy response in the next computer tomography (analogous to RECIST v1.1)'}, {'measure': 'Treatment Toxicity', 'timeFrame': 'assessed at baseline after 12 weeks and 24 weeks of enrolment', 'description': 'Treatment toxicity encompasses the adverse effects experienced by individuals undergoing chemotherapy and exercise regimens concurrently. These effects may manifest as physical symptoms such as fatigue, nausea, muscle weakness, and decreased immune function, which can impact overall well-being and treatment adherence. Monitoring and managing toxicity levels are crucial to ensure patient safety and optimize treatment outcomes. Additionally, integrating exercise interventions alongside chemotherapy may pose unique challenges, as physical activity can exacerbate certain side effects or interact with treatment efficacy. Therefore, careful monitoring and personalized exercise prescriptions are essential to mitigate toxicity risks and enhance the overall tolerability and effectiveness of combined therapy approaches. Toxicity will be reported with CTCAE v5.0'}, {'measure': 'Treatment scheme', 'timeFrame': 'assessed at baseline after 12 weeks and 24 weeks of enrolment', 'description': 'Change in dose or frequency during trial participation'}, {'measure': 'NT-pro-BNP', 'timeFrame': 'Up to 24 weeks', 'description': 'Concentration of N-terminal prohormone of brain natriuretic peptide (NT-pro-BNP), measured in picograms per milliliter (pg/mL) of blood'}, {'measure': 'High sensitive troponin I', 'timeFrame': 'Up to 24 weeks', 'description': 'Concentration of troponin I in nanograms per milliliter \\[ng/mL\\] of blood.'}, {'measure': 'Erythrocytes', 'timeFrame': 'Up to 24 weeks', 'description': 'The amount of Erythrocytes per liter \\[/pl\\]'}, {'measure': 'Hemoglobin', 'timeFrame': 'Up to 24 weeks', 'description': 'Concentration of hemoglobin in the blood, measured in grams per deciliter (g/dL)'}, {'measure': 'Leukocytes', 'timeFrame': 'Up to 24 weeks', 'description': 'Count of leukocytes per nanoliter \\[ /nl\\]'}, {'measure': 'Lymphocytes', 'timeFrame': 'Up to 24 weeks', 'description': 'Count of lymphocytes per nanoliter \\[ /nl\\]'}, {'measure': 'Neutrophils', 'timeFrame': 'Up to 24 weeks', 'description': 'Count of neutrophils per nanoliter \\[ /nl\\]'}, {'measure': 'CRP', 'timeFrame': 'Up to 24 weeks', 'description': 'Concentration of C-reactive protein (CRP) in the blood, measured in milligrams per deciliter \\[mg/dL\\]'}, {'measure': 'CYRFRA 21-1', 'timeFrame': 'Up to 24 weeks', 'description': 'Concentration of cytokeratin-19 fragment (CYFRA 21-1) in nanograms per milliliter \\[ng/mL\\] of blood'}, {'measure': 'Physical function (Hypothetical One-repetition maximum)', 'timeFrame': 'assessed at baseline after 12 weeks and 24 weeks of enrolment', 'description': 'Leg press \\[kg.\\], Latissimus pulldown \\[kg.\\], bench press \\[kg.\\], Crunch \\[kg.\\], Leg curl \\[kg.\\], Back extension \\[kg.\\]'}, {'measure': 'Blood gas analysis pH value', 'timeFrame': 'assessed at baseline, after 12 weeks and 24 weeks of enrolment', 'description': 'pH value'}, {'measure': 'Blood gas analysis (PAO2)', 'timeFrame': 'assessed at baseline, after 12 weeks and 24 weeks of enrolment', 'description': 'Partial pressure of oxygen in arterial blood (PAO2 \\[mmHg\\])'}, {'measure': 'Blood gas analysis (SaO2)', 'timeFrame': 'assessed at baseline, after 12 weeks and 24 weeks of enrolment', 'description': 'Arterial oxygen saturation, measured as a percentage (SaO2 \\[%\\])'}, {'measure': 'Blood gas analysis (PCO2)', 'timeFrame': 'assessed at baseline, after 12 weeks and 24 weeks of enrolment', 'description': 'Partial pressure of carbon dioxide in arterial blood PCO2 \\[mmHg\\]'}, {'measure': 'Blood gas analysis (BE)', 'timeFrame': 'assessed at baseline, after 12 weeks and 24 weeks of enrolment', 'description': 'Base excess (BE) represents the amount of excess or deficit of base (primarily bicarbonate, HCO3-) in the blood \\[mmol/l\\]'}, {'measure': 'Blood gas analysis (HCO3)', 'timeFrame': 'assessed at baseline, after 12 weeks and 24 weeks of enrolment', 'description': 'Bicarbonate concentration in the blood HCO3 \\[mmol/l\\]'}, {'measure': 'Blood gas analysis (SBCe)', 'timeFrame': 'assessed at baseline, after 12 weeks and 24 weeks of enrolment', 'description': 'Bicarbonate Concentration in the extracellular fluid SBCe \\[mmol/l\\]'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Lung Carcinoma', 'First Line Treatment', 'Second Line Treatment', 'NSCLC Stage IV', 'NSCLC Stage IIIB', 'Palliative Treatment', 'NSCLC Stage IIIC']}, '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Patients with histologically confirmed non-small cell lung carcinoma in UICC stages IIIB and IV\n* First- or second-line therapy (inclusion up to 28 days after the first cycle) in palliative intention\n* Age ≥ 18 years\n* Signed informed consent\n\nExclusion Criteria\n\n* Severe cardiopulmonary disease (EF\\<30%)\n* Newly occurring or progressive uncontrolled CNS (central nervous system) metastases\n* Expected life expectancy \\< 3 months\n* Bone metastases with acute risk of fracture\n* ECOG (Eastern Cooperative Oncology Group) performance status \\> 2\n* Acute pulmonary embolism\n* Acute myocardial infarction\n* Requiring surgery for aortic aneurysm\n* Tension pneumothorax\n* Lack of proficiency in the German language\n* Active infection'}, 'identificationModule': {'nctId': 'NCT06374160', 'acronym': 'BREATH', 'briefTitle': 'Exercise in Patients With Advanced Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Essen'}, 'officialTitle': 'Better Symptom Control With Exercise in Patients With Advanced Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '70115371'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (endurance training + strength training)', 'description': 'Frequency: 2 supervised exercise sessions per week.\n\nSession Breakdown:\n\nDuration: 60 minutes per session. Aerobic Endurance Training: 20 minutes. Strength Training: 40 minutes.\n\nAerobic Interval Training:\n\nSet at 50% of maximal workload based on spiroergometry. Five sets of 2 minutes of exertion; 5 sets of 1 minute of recovery; Total exertion time: 20 minutes\n\nStrength Training:\n\nMuscle Groups Targeted: Major muscle groups. Sets and Repetitions: 2 sets with 8-12 repetitions.\n\nTraining Intensity:\n\nRange: 50-80% of 1-RM (1-repetition maximum)', 'interventionNames': ['Behavioral: Exercise intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B (endurance exercise)', 'description': 'Frequency: 2 supervised exercise sessions per week.\n\nSession Breakdown:\n\nDuration: Approximately 30 minutes. Focus: Aerobic endurance training. Followed by 10 minutes of Respiratory therapy.\n\nEndurance Training:\n\nMethod: Intervals for a balance between exertion and recovery. Intensity: Set at 50% of maximal workload based on spiroergometry.', 'interventionNames': ['Behavioral: Exercise intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Arm C (Usual Care)', 'description': 'The control group receives a one-time sports consultation with general information about daily activities and sports participation, as well as individual training recommendations. After the 12 weeks, the control group will be randomized into one of the exercise therapies.'}], 'interventions': [{'name': 'Exercise intervention', 'type': 'BEHAVIORAL', 'description': 'Exercise', 'armGroupLabels': ['Arm A (endurance training + strength training)', 'Arm B (endurance exercise)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45147', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'contacts': [{'name': 'Mitra Tewes, PD. Dr.', 'role': 'CONTACT', 'email': 'mitra.tewes@uk-essen.de'}, {'name': 'Nico De Lazzari, M. Sc.', 'role': 'CONTACT', 'email': 'nico.delazzari@uk-essen.de', 'phone': '+49 201 723-82035'}, {'name': 'Mitra Tewes, PD. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marcel Wiesweg, PD. Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Miriam Götte, PD. Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eva-Maria Hüßler, Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Andreas Stang, Prof. Dr.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Matthias Totzeck, Prof. Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'West German Cancer Center (Department of Palliative medicine and Department of Medical Oncology), University Hospital Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'centralContacts': [{'name': 'Nico De Lazzari, M. Sc.', 'role': 'CONTACT', 'email': 'nico.delazzari@uk-essen.de', 'phone': '+49 201 / 723-82035'}, {'name': 'Mitra Tewes, PD. Dr.', 'role': 'CONTACT', 'email': 'mitra.tewes@uk-essen.de', 'phone': '+49 201 723 7262'}], 'overallOfficials': [{'name': 'Mitra Tewes, PD. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Palliative Medicine, University Hospital Essen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will publish a study protocol, including the statistical analysis plan, at an international peer-reviewed journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Essen', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Cancer Aid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}