Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Active, not recruiting Not applicable

High Intensity Aerobic Exercise Training and Immune Cell Mobilization in Patients With Lung Cancer (HI AIM)

NCT04263467 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2020-08-17
Last updated
2025-03-17

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
Herlev Hospital Herlev Denmark
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04263467 on ClinicalTrials.gov ↗ ← All trials in Denmark