NCT Number: NCT06374160
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Essen, North Rhine-Westphalia, 45147, Germany
Andreas Stang, Prof. Dr.
SUB_INVESTIGATOR
Eva-Maria Hüßler, Dr.
SUB_INVESTIGATOR
Marcel Wiesweg, PD. Dr.
SUB_INVESTIGATOR
Matthias Totzeck, Prof. Dr.
SUB_INVESTIGATOR
Miriam Götte, PD. Dr.
SUB_INVESTIGATOR
Mitra Tewes, PD. Dr.
CONTACT
Mitra Tewes, PD. Dr.
PRINCIPAL_INVESTIGATOR
Nico De Lazzari, M. Sc.
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exercise
Time frame: assessed at Baseline, after 12 weeks and 24 weeks of enrolment
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.
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
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.
Time frame: assessed at baseline after 12 weeks and 24 weeks of enrolment
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.
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
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.
Time frame: assessed at Baseline, after 12 weeks and 24 weeks of enrolment
Change during study participation (mmHg)
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Changes in 12-lead resting ECG, including PQ [ms], QRS [ms], and QT [ms] intervals
Time frame: Through study completion, an average of 12 weeks
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.
Time frame: Through study completion, an average of 12 weeks
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.
Time frame: At Baseline
The recruitment rate quantifies the speed of participant enrollment for a study.
Time frame: Through study completion, an average of 12 weeks
Safety analyses will be based on Adverse Events (AEs), Serious Adverse Events (SAEs) after the Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: Baseline and after 12 weeks
Therapy response in the next computer tomography (analogous to RECIST v1.1)
Time frame: assessed at baseline after 12 weeks and 24 weeks of enrolment
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
Time frame: assessed at baseline after 12 weeks and 24 weeks of enrolment
Change in dose or frequency during trial participation
Time frame: Up to 24 weeks
Concentration of N-terminal prohormone of brain natriuretic peptide (NT-pro-BNP), measured in picograms per milliliter (pg/mL) of blood
Time frame: Up to 24 weeks
Concentration of troponin I in nanograms per milliliter [ng/mL] of blood.
Time frame: Up to 24 weeks
The amount of Erythrocytes per liter [/pl]
Time frame: Up to 24 weeks
Concentration of hemoglobin in the blood, measured in grams per deciliter (g/dL)
Time frame: Up to 24 weeks
Count of leukocytes per nanoliter [ /nl]
Time frame: Up to 24 weeks
Count of lymphocytes per nanoliter [ /nl]
Time frame: Up to 24 weeks
Count of neutrophils per nanoliter [ /nl]
Time frame: Up to 24 weeks
Concentration of C-reactive protein (CRP) in the blood, measured in milligrams per deciliter [mg/dL]
Time frame: Up to 24 weeks
Concentration of cytokeratin-19 fragment (CYFRA 21-1) in nanograms per milliliter [ng/mL] of blood
Time frame: assessed at baseline after 12 weeks and 24 weeks of enrolment
Leg press [kg.], Latissimus pulldown [kg.], bench press [kg.], Crunch [kg.], Leg curl [kg.], Back extension [kg.]
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
pH value
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Partial pressure of oxygen in arterial blood (PAO2 [mmHg])
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Arterial oxygen saturation, measured as a percentage (SaO2 [%])
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Partial pressure of carbon dioxide in arterial blood PCO2 [mmHg]
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Base excess (BE) represents the amount of excess or deficit of base (primarily bicarbonate, HCO3-) in the blood [mmol/l]
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Bicarbonate concentration in the blood HCO3 [mmol/l]
Time frame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Bicarbonate Concentration in the extracellular fluid SBCe [mmol/l]
Contact information is provided by the study sponsor or research team.
Mitra Tewes, PD. Dr.
CONTACT
Nico De Lazzari, M. Sc.
CONTACT
+49 201 / 723-82035
University Hospital, Essen
Other
Better Symptom Control With Exercise in Patients With Advanced Non-small Cell Lung Cancer
Acronym: BREATH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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