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.
Research has shown that exercise training has several beneficial effects in cancer patients and survivors both during and after anti-cancer treatment, including improved physical function, reduction of symptoms, reduction of side effects and improved quality of life (QoL). In addition, a physical active lifestyle is associated with reduced risk of some cancers. Recent data in mouse models have shown that tumor-bearing mice randomized to a voluntary wheel running group showed over 60% reduction in tumor incidence and progression in several tumor models. Moreover, the mouse data clearly showed homing of T and natural killer (NK) cells to tumors in an exercise dependent manner, underscoring that exercise may render patients more prone to respond to therapy. However, most of the underlying biological mechanisms leading to the documented beneficial effects of physical exercise in relation to cancer are yet unknown, but exercise-mediated changes in hormone levels, inflammation and immune cell function are thought to play a key role. Included participants will be randomized 1:1 to an intervention group and a control group. Participants in the intervention group will receive a six-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. Participants in the control group will still receive standard oncological treatments; immune checkpoint inhibitors, checkpoint inhibitors combined with chemotherapy or oncological surveillance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
The exercise intervention will consist a intermediate to high aerobic exercise training program.
Standard oncological treatments
Herlev Hospital
Herlev, Denmark
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.
Time frame: 0 - 36 months
Maximal aerobic capacity
Measure difference in maximal aerobic capacity before and after exercise intervention.
Time frame: 0 - 36 months
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.
Time frame: 0 - 36 months
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.
Time frame: 0 - 36 months
Overall survival
Overall Survival (OS), defined as time from treatment initiation to death, will be described with use of Kaplan Meier curve.
Time frame: 0 - 36 months
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)
Time frame: 0 - 36 months
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