Exercise in Patients With Advanced Non-small Cell Lung Cancer

NSCLC Stage IV Clinical Trial

— BREATH  

Official title:

Better Symptom Control With Exercise in Patients With Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06374160
• Other study ID #: 70115371
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: August 31, 2026

Study information

• Verified date: April 2024
• Source: University Hospital, Essen
• Contact: Nico De Lazzari, M. Sc.
• Phone: +49 201 / 723-82035
• Email: nico.delazzari[@]uk-essen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: August 31, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Lung Carcinoma
• Carcinoma, Non-Small-Cell Lung
• First Line Treatment
• Lung Neoplasms
• NSCLC Stage IIIB
• NSCLC Stage IV
• Palliative Treatment
• Second Line Treatment

Intervention

Behavioral:
• Exercise intervention
Exercise

Locations

Country	Name	City	State
Germany	West German Cancer Center (Department of Palliative medicine and Department of Medical Oncology), University Hospital Essen	Essen	North Rhine-Westphalia

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Essen	German Cancer Aid

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F)	The FACT-F is a 13-item questionnaire to assess fatigue in cancer patients. Subscale are physical well-being, social/family well-being, emotional well-being, functional well-being and the fatigue subscale. Based on the subscale the FACIT-F trial outcome index (TOI) Score range 0-108, FACT-G total score (Score range 0-108) and FACIT-F total score (Score range 0-160) can be calculated. The higher the score, the better the Quality of Life.	assessed at baseline, after 12 weeks and 24 weeks of enrolment
Secondary	European Organisation for Research and Treatment of Cancer (EORTC QLQ C30)	The EORTC QLQ Core Questionnaire is a 30-item instrument meant to assess some of the different aspects that define the quality of life of cancer patients (e.g., physical function, emotional function, symptom scales, and Quality of Life). High scores for functional scales (score 0-100) represent a high level of functioning, high scores for the global health status represent a high quality of life (score 0-100), high scores for symptom scales (score 0-100) represent a high level of symptomatology.	assessed at baseline after 12 weeks and 24 weeks of enrolment
Secondary	European Organisation for Research and Treatment of Cancer Lung cancer module (EORTC-LC13)	The LC13 is a modular supplement to the EORTC-C30 for assessment of symptoms in clinical lung. cancer trials. The scoring range is between 0 to 100, a high score indicating a high level of symptomatology.	assessed at baseline, after 12 weeks and 24 weeks of enrolment
Secondary	Arterial blood pressure	Change during study participation (mmHg)	assessed at Baseline, after 12 weeks and 24 weeks of enrolment
Secondary	Change in ECG	Changes in 12-lead resting ECG, including PQ [ms], QRS [ms], and QT [ms] intervals	assessed at baseline, after 12 weeks and 24 weeks of enrolment
Secondary	Adherence to exercise intervention	The exercise physiologist monitored adherence to the supervised sessions. Based on the absolute numbers of scheduled exercise sessions, both absolute and percentage-based adherence can be calculated and compared between study arms.	Through study completion, an average of 12 weeks
Secondary	Drop-out rate	All withdrawals will be considered as dropouts, with reasons noted. Compare the total number of dropouts in each study arm. This provides a straightforward comparison of the raw dropout counts between groups. Also, calculate the percentage of participants who dropped out in each study arm relative to the total number of participants initially assigned to that arm. This allows for a comparison of dropout rates relative to the initial sample size and compared between study arms.	Through study completion, an average of 12 weeks
Secondary	Recruitment rate	The recruitment rate quantifies the speed of participant enrollment for a study.	At Baseline
Secondary	Serious Adverse Event/Adverse Events	Safety analyses will be based on Adverse Events (AEs), Serious Adverse Events (SAEs) after the Common Terminology Criteria for Adverse Events (CTCAE) v5.0	Through study completion, an average of 12 weeks
Secondary	Therapy response	Therapy response in the next computer tomography (analogous to RECIST v1.1)	Baseline and after 12 weeks
Secondary	Treatment Toxicity	Treatment toxicity encompasses the adverse effects experienced by individuals undergoing chemotherapy and exercise regimens concurrently. These effects may manifest as physical symptoms such as fatigue, nausea, muscle weakness, and decreased immune function, which can impact overall well-being and treatment adherence. Monitoring and managing toxicity levels are crucial to ensure patient safety and optimize treatment outcomes. Additionally, integrating exercise interventions alongside chemotherapy may pose unique challenges, as physical activity can exacerbate certain side effects or interact with treatment efficacy. Therefore, careful monitoring and personalized exercise prescriptions are essential to mitigate toxicity risks and enhance the overall tolerability and effectiveness of combined therapy approaches. Toxicity will be reported with CTCAE v5.0	assessed at baseline after 12 weeks and 24 weeks of enrolment
Secondary	Treatment scheme	Change in dose or frequency during trial participation	assessed at baseline after 12 weeks and 24 weeks of enrolment
Secondary	NT-pro-BNP	Concentration of N-terminal prohormone of brain natriuretic peptide (NT-pro-BNP), measured in picograms per milliliter (pg/mL) of blood	Up to 24 weeks
Secondary	High sensitive troponin I	Concentration of troponin I in nanograms per milliliter [ng/mL] of blood.	Up to 24 weeks
Secondary	Erythrocytes	The amount of Erythrocytes per liter [/pl]	Up to 24 weeks
Secondary	Hemoglobin	Concentration of hemoglobin in the blood, measured in grams per deciliter (g/dL)	Up to 24 weeks
Secondary	Leukocytes	Count of leukocytes per nanoliter [ /nl]	Up to 24 weeks
Secondary	Lymphocytes	Count of lymphocytes per nanoliter [ /nl]	Up to 24 weeks
Secondary	Neutrophils	Count of neutrophils per nanoliter [ /nl]	Up to 24 weeks
Secondary	CRP	Concentration of C-reactive protein (CRP) in the blood, measured in milligrams per deciliter [mg/dL]	Up to 24 weeks
Secondary	CYRFRA 21-1	Concentration of cytokeratin-19 fragment (CYFRA 21-1) in nanograms per milliliter [ng/mL] of blood	Up to 24 weeks
Secondary	Physical function (Hypothetical One-repetition maximum)	Leg press [kg.], Latissimus pulldown [kg.], bench press [kg.], Crunch [kg.], Leg curl [kg.], Back extension [kg.]	assessed at baseline after 12 weeks and 24 weeks of enrolment
Secondary	Blood gas analysis pH value	pH value	assessed at baseline, after 12 weeks and 24 weeks of enrolment
Secondary	Blood gas analysis (PAO2)	Partial pressure of oxygen in arterial blood (PAO2 [mmHg])	assessed at baseline, after 12 weeks and 24 weeks of enrolment
Secondary	Blood gas analysis (SaO2)	Arterial oxygen saturation, measured as a percentage (SaO2 [%])	assessed at baseline, after 12 weeks and 24 weeks of enrolment
Secondary	Blood gas analysis (PCO2)	Partial pressure of carbon dioxide in arterial blood PCO2 [mmHg]	assessed at baseline, after 12 weeks and 24 weeks of enrolment
Secondary	Blood gas analysis (BE)	Base excess (BE) represents the amount of excess or deficit of base (primarily bicarbonate, HCO3-) in the blood [mmol/l]	assessed at baseline, after 12 weeks and 24 weeks of enrolment
Secondary	Blood gas analysis (HCO3)	Bicarbonate concentration in the blood HCO3 [mmol/l]	assessed at baseline, after 12 weeks and 24 weeks of enrolment
Secondary	Blood gas analysis (SBCe)	Bicarbonate Concentration in the extracellular fluid SBCe [mmol/l]	assessed at baseline, after 12 weeks and 24 weeks of enrolment