High Intensity Aerobic Exercise Training and Immune Cell Mobilization in Patients With Lung Cancer (HI AIM) (HIAIM)
Cancer, Cancer of Lung
About this trial
This is an interventional treatment trial for Cancer
Eligibility Criteria
Inclusion Criteria:
- Metastatic non-small cell lung cancer
- Measurable disease according to RECIST 1.1
- Age ≥ 18 years
- Treatment with immune checkpoint inhibitors, checkpoint inhibitors combined with chemotherapy or oncological surveillance
- Eastern Cooperative Oncology Group (ECOG) performance status score (PS) ≤2
- Preferably metastasis suitable for biopsy
Normal marrow function as defined below:
- White blood cell count (WBC) ≥ 2 x 10⁹/L
- Absolute neutrophil count (ANC) ≥ 1.5 x 10⁹/L
- Hemoglobin ≥ 6.0 mmol/l
- Platelet count ≥ 100 x 10⁹/L
- In case, a patient's bone marrow values fall slightly below the described values, the treatment responsible doctor will be consulted. The general health and the ability to proceed with the treatment will be considered.
- Ability to speak and read Danish
- Willingness to give informed consent for participation in the study
Exclusion Criteria:
- Any physical condition that hinder the execution of physical exercise, as assessed by the referring oncologist and by a physiotherapist
- Severe dyspnea that hinder the execution of high intensity aerobic exercise training, as assessed by the referring oncologist
- Symptomatic brain metastases
- Dementia, psychotic disorders, or other cognitive diseases or conditions that hinder participation in a clinical exercise-based trial, as assessed by the referring oncologist
- Unstable medical disease or history of serious or concurrent illness; any medical condition that might be aggravated by exercise training or that cannot be controlled, including, but not restricted to congestive heart failure (NYHA class III-IV), unstable angina pectoris, implantable cardioverter defibrillator (ICD), or myocardial infarction within 6 months
- A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications. Inhaled or topical steroids and adrenal replacement doses ≤ 10 mg daily prednisone equivalents are permitted
- Use of beta blockers
- Any systemic infections within the last 4 weeks
- Patients who receives chemotherapy as monotherapy
In patients with documented bone metastases; patients with:
- A bone metastatic burden or location that poses a risk of injury in the performance of exercise training, as assessed by the referring oncologist
Sites / Locations
- Herlev HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Intervention group
Control group
Participants in the intervention group will receive a 6-weeks exercise-based intervention with supervised and group-based exercise training three times a week at the hospital setting. Each training session will consist of intermediate and high intensity interval training. The exercise-based intervention will be combined with standard oncological treatments; checkpoint inhibitors, checkpoint inhibitors combined with chemotherapy or oncological surveillance. Additional monitoring of patient will include physical tests, questionnaires and blood samples.
Participants in the control group will receive standard oncological treatments; immune checkpoint inhibitors, checkpoint inhibitors combined with chemotherapy or oncological surveillance. Additional monitoring of patient will include physical tests, questionnaires and blood samples.