Active, not recruiting
Not applicable
High Intensity Aerobic Exercise Training and Immune Cell Mobilization in Patients With Lung Cancer (HI AIM)
Condition(s) studied
CancerCancer of Lung
Investigational drug(s) / intervention(s)
Exercise interventionStandard oncological treatments
Exercise intervention: The exercise intervention will consist a intermediate to high aerobic exercise training program.
Standard oncological treatments: Standard oncological treatments
Study summary
The purpose of this study is to investigate if high-intensive training can mobilize and activate the immune system, and thereby enhance the effect of the conventional treatment of lung cancer patients. An important aspect of this study will investigate if the presence of various proteins and cells in blood and tumor biopsies can verify or predict the effect of the high-intensive training. In this clinical trial, patients with lung cancer will combine their conventional therapy with a six-week exercise program.
Eligibility
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
Primary outcome measure(s)
- Circulating NK cells — 0 - 36 months
Flow cytometry will be used to analyse and determine amount of circulating NK cells. The analysis will focus on absolute counts of NK cells, but also surface expression of various surface markers of interest.
Trial sites (1)
| Facility | City | Region | Status |
| Herlev Hospital |
Herlev |
Denmark |
|
More Herlev Hospital trials in Denmark
Other trials for the same condition