Exercise in Patients With Advanced Non-small Cell Lung Cancer (BREATH)

University Hospital Essen

Status: Not yet enrolling

Conditions: NSCLC Stage IV; Second Line Treatment; Advanced Lung Carcinoma; Palliative Treatment; First Line Treatment; NSCLC Stage IIIB; NSCLC Stage IIIC

Treatments: Behavioral: Exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06374160

70115371

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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104 participants in 3 patient groups

Arm A (endurance training + strength training)

Experimental group

Description:

Frequency: 2 supervised exercise sessions per week. Session Breakdown: Duration: 60 minutes per session. Aerobic Endurance Training: 20 minutes. Strength Training: 40 minutes. Aerobic Interval Training: Set 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 Strength Training: Muscle Groups Targeted: Major muscle groups. Sets and Repetitions: 2 sets with 8-12 repetitions. Training Intensity: Range: 50-80% of 1-RM (1-repetition maximum)

Treatment:

Behavioral: Exercise intervention

Arm B (endurance exercise)

Experimental group

Description:

Frequency: 2 supervised exercise sessions per week. Session Breakdown: Duration: Approximately 30 minutes. Focus: Aerobic endurance training. Followed by 10 minutes of Respiratory therapy. Endurance Training: Method: Intervals for a balance between exertion and recovery. Intensity: Set at 50% of maximal workload based on spiroergometry.

Treatment:

Behavioral: Exercise intervention

Arm C (Usual Care)

No Intervention group

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.