Exercise in Patients With Advanced Non-small Cell Lung Cancer

Trial Title: Exercise in Patients With Advanced Non-small Cell Lung Cancer

NCT ID: NCT06374160

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

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Crossover Assignment

Intervention model description: 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.

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Exercise intervention
Description: Exercise
Arm group label: Arm A (endurance training + strength training)
Arm group label: Arm B (endurance exercise)

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

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

Address:
City: Essen
Zip: 45147
Country: Germany

Contact:
Last name: Mitra Tewes, PD. Dr.
Email: mitra.tewes@uk-essen.de

Contact backup:
Last name: Nico De Lazzari, M. Sc.

Phone: +49 201 723-82035
Email: nico.delazzari@uk-essen.de

Investigator:
Last name: Mitra Tewes, PD. Dr.
Email: Principal Investigator

Investigator:
Last name: Marcel Wiesweg, PD. Dr.
Email: Sub-Investigator

Investigator:
Last name: Miriam Götte, PD. Dr.
Email: Sub-Investigator

Investigator:
Last name: Eva-Maria Hüßler, Dr.
Email: Sub-Investigator

Investigator:
Last name: Andreas Stang, Prof. Dr.
Email: Sub-Investigator

Investigator:
Last name: Matthias Totzeck, Prof. Dr.
Email: Sub-Investigator

Start date: May 1, 2024

Completion date: August 31, 2026

Lead sponsor:
Agency: University Hospital, Essen
Agency class: Other

Collaborator:
Agency: German Cancer Aid
Agency class: Other

Source: University Hospital, Essen

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06374160