Exercise in Patients With Advanced Non-small Cell Lung Cancer

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Exercise intervention
  Exercise

Первичные конечные точки

• Maximum oxygen uptake (VO2 peak [ml/min/kg]) [Срок оценки: assessed at Baseline, after 12 weeks and 24 weeks of enrolment]

Вторичные конечные точки (12)

• Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F) [Срок оценки: assessed at baseline, after 12 weeks and 24 weeks of enrolment]
• European Organisation for Research and Treatment of Cancer (EORTC QLQ C30) [Срок оценки: assessed at baseline after 12 weeks and 24 weeks of enrolment]
• European Organisation for Research and Treatment of Cancer Lung cancer module (EORTC-LC13) [Срок оценки: assessed at baseline, after 12 weeks and 24 weeks of enrolment]
• Arterial blood pressure [Срок оценки: assessed at Baseline, after 12 weeks and 24 weeks of enrolment]
• Change in ECG [Срок оценки: assessed at baseline, after 12 weeks and 24 weeks of enrolment]
• Adherence to exercise intervention [Срок оценки: Through study completion, an average of 12 weeks]
• Drop-out rate [Срок оценки: Through study completion, an average of 12 weeks]
• Recruitment rate [Срок оценки: At Baseline]
• Serious Adverse Event/Adverse Events [Срок оценки: Through study completion, an average of 12 weeks]
• Therapy response [Срок оценки: Baseline and after 12 weeks]
• Treatment Toxicity [Срок оценки: assessed at baseline after 12 weeks and 24 weeks of enrolment]
• Treatment scheme [Срок оценки: assessed at baseline after 12 weeks and 24 weeks of enrolment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Германия · 1 центр

• West German Cancer Center (Department of Palliative medicine and Department of Medical Onc — Essen

Публикации

• 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;27(1):88. doi: 10.1186/s13063-025-09416-2. PMID 41546104

Идентификаторы

NCT: NCT06374160 · 70115371

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗