Exercise in Patients With Advanced Non-small Cell Lung Cancer

NCT ID: NCT06374160

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2026-08-31

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm A (endurance training + strength training)

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)

Group Type: EXPERIMENTAL

Exercise intervention

Intervention Type: BEHAVIORAL

Exercise

Arm B (endurance exercise)

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.

Group Type: EXPERIMENTAL

Exercise intervention

Intervention Type: BEHAVIORAL

Exercise

Arm C (Usual Care)

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise intervention

Exercise

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Cancer Aid

OTHER

Sponsor Role: collaborator

University Hospital, Essen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitra Tewes, PD. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Palliative Medicine, University Hospital Essen

Locations

West German Cancer Center (Department of Palliative medicine and Department of Medical Oncology), University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Countries

Germany

Central Contacts

Nico De Lazzari, M. Sc.

Role: CONTACT

nico.delazzari@uk-essen.de

+49 201 / 723-82035

Mitra Tewes, PD. Dr.

Role: CONTACT

mitra.tewes@uk-essen.de

+49 201 723 7262

Facility Contacts

Mitra Tewes, PD. Dr.

Role: primary

mitra.tewes@uk-essen.de

Nico De Lazzari, M. Sc.

Role: backup

nico.delazzari@uk-essen.de

+49 201 723-82035

Other Identifiers

70115371

Identifier Type: -

Identifier Source: org_study_id