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

NCT04263467 | Active Not Recruiting DMC

• 1 other identifier: LU2006
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Cancer of Lung

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Maximal aerobic capacity

  0 - 36 months

• Circulating T cells and B cells.

  0 - 36 months

• Circulating serum markers of inflammation

  0 - 36 months

• Overall survival

  0 - 36 months

• Progression free survival (PFS)

  0 - 36 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in the intervention group will receive a 6-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. Additional monitoring of patient will include physical tests, questionnaires and blood samples.

Other: Exercise intervention

Control group

EXPERIMENTAL

Participants in the control group will receive standard oncological treatments; immune checkpoint inhibitors, checkpoint inhibitors combined with chemotherapy or oncological surveillance. Additional monitoring of patient will include physical tests, questionnaires and blood samples.

Other: Standard oncological treatments

Interventions

Exercise intervention OTHER

The exercise intervention will consist a intermediate to high aerobic exercise training program.

Intervention group

Standard oncological treatments OTHER

Standard oncological treatments

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

Location

Related Publications (1)

• Holmen Olofsson G, Mikkelsen MK, Ragle AM, Christiansen AB, Olsen AP, Heide-Ottosen L, Horsted CB, Pedersen CMS, Engell-Noerregaard L, Lorentzen T, Persson GF, Vinther A, Nielsen DL, Thor Straten P. High Intensity Aerobic exercise training and Immune cell Mobilization in patients with lung cancer (HI AIM)-a randomized controlled trial. BMC Cancer. 2022 Mar 5;22(1):246. doi: 10.1186/s12885-022-09349-y.

  PMID: 35247994 DERIVED

MeSH Terms

Conditions

Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Per thor Straten, Professor

  CCIT

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 10, 2020
• Study Start: August 17, 2020
• Primary Completion: January 22, 2024
• Study Completion: December 31, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)