Clinical trial NCT06374160: Exercise in Patients With Advanced Non-small Cell Lung Cancer
Official title: Better Symptom Control With Exercise in Patients With Advanced Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Advanced Lung Carcinoma
First Line Treatment
Second Line Treatment
NSCLC Stage IV
NSCLC Stage IIIB
Palliative Treatment
NSCLC Stage IIIC
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
Collaborators: name: German Cancer Aid
First posted: 2024-04-18
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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

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.


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

Primary outcomes:
measure: Maximum oxygen uptake (VO2 peak [ml/min/kg])
timeFrame: assessed at Baseline, after 12 weeks and 24 weeks of enrolment
Secondary outcomes:
measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F)
timeFrame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
measure: European Organisation for Research and Treatment of Cancer (EORTC QLQ C30)
timeFrame: assessed at baseline after 12 weeks and 24 weeks of enrolment
measure: European Organisation for Research and Treatment of Cancer Lung cancer module (EORTC-LC13)
timeFrame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
measure: Arterial blood pressure
timeFrame: assessed at Baseline, after 12 weeks and 24 weeks of enrolment
measure: Change in ECG
timeFrame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
measure: Adherence to exercise intervention
timeFrame: Through study completion, an average of 12 weeks
measure: Drop-out rate
timeFrame: Through study completion, an average of 12 weeks
measure: Recruitment rate
timeFrame: At Baseline
measure: Serious Adverse Event/Adverse Events
timeFrame: Through study completion, an average of 12 weeks
measure: Therapy response
timeFrame: Baseline and after 12 weeks
measure: Treatment Toxicity
timeFrame: assessed at baseline after 12 weeks and 24 weeks of enrolment
measure: Treatment scheme
timeFrame: assessed at baseline after 12 weeks and 24 weeks of enrolment
measure: NT-pro-BNP
timeFrame: Up to 24 weeks
measure: High sensitive troponin I
timeFrame: Up to 24 weeks
measure: Erythrocytes
timeFrame: Up to 24 weeks
measure: Hemoglobin
timeFrame: Up to 24 weeks
measure: Leukocytes
timeFrame: Up to 24 weeks
measure: Lymphocytes
timeFrame: Up to 24 weeks
measure: Neutrophils
timeFrame: Up to 24 weeks
measure: CRP
timeFrame: Up to 24 weeks
measure: CYRFRA 21-1
timeFrame: Up to 24 weeks
measure: Physical function (Hypothetical One-repetition maximum)
timeFrame: assessed at baseline after 12 weeks and 24 weeks of enrolment
measure: Blood gas analysis pH value
timeFrame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
measure: Blood gas analysis (PAO2)
timeFrame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
measure: Blood gas analysis (SaO2)
timeFrame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
measure: Blood gas analysis (PCO2)
timeFrame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
measure: Blood gas analysis (BE)
timeFrame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
measure: Blood gas analysis (HCO3)
timeFrame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
measure: Blood gas analysis (SBCe)
timeFrame: assessed at baseline, after 12 weeks and 24 weeks of enrolment
Other outcomes:
Locations:
city: Essen
country: Germany
facility: West German Cancer Center (Department of Palliative medicine and Department of Medical Oncology), University Hospital Essen
state: North Rhine-Westphalia
Study officials:
affiliation: Department of Palliative Medicine, University Hospital Essen
name: Mitra Tewes, PD. Dr.
role: PRINCIPAL_INVESTIGATOR
References: