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

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ClinicalTrials.gov Identifier: NCT04263467
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
Per thor Straten, Herlev Hospital

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.

Condition or disease Intervention/treatment Phase
Cancer Cancer of Lung Other: Exercise intervention Other: Standard oncological treatments Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Intensity Aerobic Exercise Training and Immune Cell Mobilization in Patients With Lung Cancer (HI AIM)
Actual Study Start Date : August 17, 2020
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention group
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
The exercise intervention will consist a intermediate to high aerobic exercise training program.

Experimental: Control group
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
Standard oncological treatments




Primary Outcome Measures :
  1. Circulating NK cells [ Time Frame: 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.


Secondary Outcome Measures :
  1. Maximal aerobic capacity [ Time Frame: 0 - 36 months ]
    Measure difference in maximal aerobic capacity before and after exercise intervention.

  2. Circulating T cells and B cells. [ Time Frame: 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 eg. PD-1.

  3. Circulating serum markers of inflammation [ Time Frame: 0 - 36 months ]
    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.

  4. Overall survival [ Time Frame: 0 - 36 months ]
    Overall Survival (OS), defined as time from treatment initiation to death, will be described with use of Kaplan Meier curve.

  5. Progression free survival (PFS) [ Time Frame: 0 - 36 months ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04263467


Contacts
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Contact: Per thor Straten, Professor 0045 38683868 per.thor.straten@regionh.dk
Contact: Gitte Holmen Olofsson, PhD 0045 38683868 gitte.holmen.olofsson@regionh.dk

Locations
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Denmark
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Per thor Straten, Prof    0045 38683868    per.thor.straten@regionh.dk   
Contact: Gitte Holmen Olofsson, PhD    0045 38683868    gitte.holmen.olofsson@regionh.dk   
Sponsors and Collaborators
Herlev Hospital
Investigators
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Study Director: Per thor Straten, Professor CCIT
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Per thor Straten, Professor, Herlev Hospital
ClinicalTrials.gov Identifier: NCT04263467    
Other Study ID Numbers: LU2006
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual participant data (IPD) sharing plan will be consider at the end of the trial.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases