Exercise in Patients With Advanced Non-small Cell Lung Cancer

NCT06374160 | Not Yet Recruiting

• 1 other identifier: 70115371
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Maximum oxygen uptake (VO2 peak [ml/min/kg])

  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.

  assessed at Baseline, after 12 weeks and 24 weeks of enrolment

Secondary Outcomes (29)

• Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F)

  assessed at baseline, after 12 weeks and 24 weeks of enrolment

• European Organisation for Research and Treatment of Cancer (EORTC QLQ C30)

  assessed at baseline after 12 weeks and 24 weeks of enrolment

• European Organisation for Research and Treatment of Cancer Lung cancer module (EORTC-LC13)

  assessed at baseline, after 12 weeks and 24 weeks of enrolment

• Arterial blood pressure

  assessed at Baseline, after 12 weeks and 24 weeks of enrolment

• Change in ECG

  assessed at baseline, after 12 weeks and 24 weeks of enrolment

Study Arms (3)

Arm A (endurance training + strength training)

EXPERIMENTAL

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)

Behavioral: Exercise intervention

Arm B (endurance exercise)

EXPERIMENTAL

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.

Behavioral: Exercise intervention

Arm C (Usual Care)

NO INTERVENTION

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

Exercise intervention BEHAVIORAL

Exercise

Arm A (endurance training + strength training); Arm B (endurance exercise)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically confirmed non-small cell lung carcinoma in UICC stages IIIB and IV
• Age ≥ 18 years
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Essen: lead
• German Cancer Aid: collaborator

Study Sites (1)

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

Essen, North Rhine-Westphalia, 45147, Germany

Location

Related Publications (1)

• De Lazzari N, Wiesweg M, Gotte M, Franco J, Mincu RI, Jager J, Huessler EM, Kuklik N, Stang A, Totzeck M, Tewes M. Improving aerobic capacity in patients with advanced non-small cell lung cancer: study protocol of the 3-armed randomized controlled BREATH trial. Trials. 2026 Jan 17. doi: 10.1186/s13063-025-09416-2. Online ahead of print.

  PMID: 41546104 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mitra Tewes, PD. Dr.

  Department of Palliative Medicine, University Hospital Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nico De Lazzari, M. Sc.

CONTACT

+49 201 / 723-82035; nico.delazzari@uk-essen.de

Mitra Tewes, PD. Dr.

CONTACT

+49 201 723 7262; mitra.tewes@uk-essen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 18, 2024
• Study Start: May 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)