High Intensity Aerobic exercise training and Immune cell Mobilization in patients with lung cancer (HI AIM)-a randomized controlled trial.

BACKGROUND: The increasing role of exercise training in cancer care is built on evidence that exercise can reduce side effects of treatment, improve physical functioning and quality of life. We and others have shown in mouse tumor models, that exercise leads to an adrenalin-mediated increased influx of T and NK cells into the tumor, altering the tumor microenvironment (TME) and leading to reduced tumor growth. These data suggest that exercise could improve immune responses against cancer cells by increase immune cell infiltration to the tumor and potentially having an impact on disease progression. Additionally, there are data to suggest that infiltration of T and NK cells into the TME is correlates with response to immune checkpoint inhibitors in patients. We have therefore initiated the clinical trial HI AIM, to investigate if high intensity exercise can mobilize and increase infiltration of immune cells in the TME in patients with lung cancer. METHODS: HI AIM (NCT04263467) is a randomized controlled trial (70 patients, 1:1) for patients with non-small cell lung cancer. Patients in the treatment arm, receive an exercise-intervention consisting of supervised and group-based exercise training, comprising primarily intermediate to high intensity interval training three times per week over 6 weeks. All patients will also receive standard oncological treatments; checkpoint inhibitors, checkpoint inhibitors combined with chemotherapy or oncological surveillance. Blood samples and biopsies (ultrasound guided), harvested before, during and after the 6-week training program, will form basis for immunological measurements of an array of immune cells and markers. Primary outcome is circulating NK cells. Secondary outcome is other circulating immune cells, infiltration of immune cells in tumor, inflammatory markers, aerobic capacity measured by VO2 max test, physical activity levels and quality of life measured by questionnaires, and clinical outcomes. DISCUSSION: To our knowledge, HI AIM is the first project to combine supervised and monitored exercise in patients with lung cancer, with rigorous analyses of immune and cancer cell markers over the course of the trial. Data from the trial can potentially support exercise as a tool to mobilize cells of the immune system, which in turn could potentiate the effect of immunotherapy. TRIAL REGISTRATION: The study was prospectively registered at ClinicalTrials.gov on February 10th 2020, ID: NCT04263467. https://clinicaltrials.gov/ct2/show/NCT04263467.

Safety and feasibility of home-based chemotherapy.

INTRODUCTION: The purpose of this study was to evaluate the safety and feasibility of home-based chemotherapy and to compare chemotherapy given at home with chemotherapy given as an outpatient treatment in relation to toxicity, quality of life and patient's preference. METHODS: Patients who had undergone radical surgery for colon cancer and who were eligible to receive adjuvant treatment with capecitabine and oxaliplatin could be included. To ensure patient safety, the first infusion was given at an outpatient clinic. Patients with adverse events graded ≤ 2 on the Common Terminology Criteria for Adverse Events version 3.0 were randomised to either group A continuing with four treatments at home followed by three in an outpatient clinic, or to group B continuing with three treatments in an outpatient clinic followed by four at home. To assess quality of life, the EuroQol-5 Domain was used at baseline and before each treatment. Preference cards were used at baseline and at end of treatment. RESULTS: A total of 51 patients were included between 2007 and 2010. Forty-two patients continued in either group A or B. The nurse found that the treatment was safe and acceptable in all cases. In 145 cycles (99.3%), patients answered that they felt secure; only one patient answered: "Do not know". The highest-ranking preferences for patients were transportation time followed by waiting time. CONCLUSIONS: Our study demonstrates that home-based chemotherapy is feasible and safe and that it might be a valuable alternative to treatment at an outpatient clinic. FUNDING: This study was supported by a grant from Roche. TRIAL REGISTRATION: not relevant.