Cancer Clinical Trial
— HIAIMOfficial title:
High Intensity Aerobic Exercise Training and Immune Cell Mobilization in Patients With Lung Cancer (HI AIM)
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | December 31, 2025 |
Est. primary completion date | October 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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 10?/L - Absolute neutrophil count (ANC) = 1.5 x 10?/L - Hemoglobin = 6.0 mmol/l - Platelet count = 100 x 10?/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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Herlev Hospital | Herlev |
Lead Sponsor | Collaborator |
---|---|
Herlev Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Circulating NK cells | 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. | 0 - 36 months | |
Secondary | Maximal aerobic capacity | Measure difference in maximal aerobic capacity before and after exercise intervention. | 0 - 36 months | |
Secondary | Circulating T cells and B cells. | 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 eg. PD-1. | 0 - 36 months | |
Secondary | Circulating serum markers of inflammation | We aim to establish a panel of serum markers that reflect the effect of exercise training. This will be establish through big panel analysis of inflammatory markers using luminex assays. We will compare serum from blood samples taken before and after exercise training. | 0 - 36 months | |
Secondary | Overall survival | Overall Survival (OS), defined as time from treatment initiation to death, will be described with use of Kaplan Meier curve. | 0 - 36 months | |
Secondary | Progression free survival (PFS) | Defined as the time from the date of randomization until the date of progressive disease (PD). This is determined by investigator assessment of objective radiographic disease assessments per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) and immune RECIST (iRECIST) | 0 - 36 months |
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