EXERCISE AND THE IMMUNE RESPONSE IN LUNG CANCER

NCT07267000 | Recruiting DMC

• 2 other identifiers: ImmuEXPAT1625724
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This project is about the effect of a 12-week training therapy intervention in patients suffering from non-small cell and small-cell lung cancer. It has widely been accepted that exercise is preventive against certain types of cancer. Individuals following an active lifestyle have a significantly lower risk for several chronic diseases, including cancer, as compared to sedentary ones. However, evidence is still lacking for exercise as part of routine cancer treatment. It has widely been accepted that exercise strongly impacts immune response, and might influence antitumor immune response as well. In this study, patients suffering from lung cancer undergo either a 12-week training program consisting of moderate-intensity continuous exercise (MICE), or a 12-week program with high-intensity interval exercise. Both groups will be compared to a control group receiving standard exercise recommendations. The immunologic response, i.e. cytokine profiles and changes in peripheral blood mononuclear cell (PBMC) characteristics will be the main endpoint. Blood will be taken from the patients at different timepoints, and blood samples will be tested for these immunologic changes. FACS analysis will be used to assess the properties of immune cells and potential changes upon the exercise regimen. Mitochondrial function will be assessed via the Seahorse machine, and mass spectrometry (lipidomics) will be used for the analysis of lipid profile changes.

Conditions

Non-Small Cell Lung Cancer; Exercise Training; Immunotherapy; Small Cell Cancer Of The Lung

Keywords

Non-small cell lung cancer; Exercise; Immunotherapy; Outcome; Small-cell lung cancer

Outcome Measures

Primary Outcomes (1)

• FACS analysis of PBMCs

  The FACS panel comprises: CD4pos Helper T Cells, CD8pos Cytotoxic T Cells, Regulatory T Cells, Effector Memory T Cells, Naive/Memory Subsets, Activated/Exhausted T Cells, gamma-delta T Cells, Naive B Cells, Memory B Cells, Transitional B Cells, Classical Monocytes, Intermediate Monocytes, Non Classical Monocytes, NK CD16pos, NK CD16neg, Neutrophils, Basophils, Mast Cells, Viable vs. Dead Cells, Immune Checkpoint Subsets, Activation/Proliferation Markers. The total numbers and percentages of cells positive for the above listed markers are the primary outcome measures. The surface marker profile of PBMCs as a whole will define the outcome, showing differences between exercising and sedentary patients, e.g.: "In patients from the exercise group, XX% of naive B cells were found, and XX% of CD4pos Helper T Cells, and XX% CD8pos Cytotoxic T Cells were found. In patients from the control group, the proportion of naive B cells was XX...".

  Before and after the 12 week training therapy intervention, i.e. differences seen between 12 and 14 weeks

Secondary Outcomes (7)

• Cytokine analysis from peripheral blood sampling

  From enrollment to after the 12 week intervention, i.e. a period between 12-14 weeks

• Number of participants with changes in mitochondrial function (Seahorse analysis)

  From enrollment to after completion of the exercise intervention, i.e. a period between 12-14 weeks

• Mass spectrometry - Lipidomics

  From enrollment to after completion of the 12 week exercise intervention, i.e. a time period between 12 and 14 weeks

• Aerobic capacity

  From enrollment to after completion of the 12 week training therapy intervention, i.e. a time period between 12 and 14 weeks

• Quality of life - EORTC-QLQ C30 (German version)

  From enrollment to after completion of the 12 week training therapy intervention, i.e. a period between 12 and 14 weeks

Study Arms (3)

Continuous Exercise

EXPERIMENTAL

Patients in this arm will undergo a 12-week training therapy regimen consisting of twice weekly supervised moderate-intensity continuous exercise (MICE) and home-based walking exercise for 30 minutes, five times a week, in addition.

Behavioral: Exercise

High Intensity Interval Exercise

EXPERIMENTAL

Patients in this arm will undergo a 12-week training therapy regimen consisting of twice weekly supervised high-intensity interval exercise and home-based walking exercise for 30 minutes, five times a week, in addition.

Behavioral: Exercise

Controls

ACTIVE COMPARATOR

Patients in this arm will receive general recommendations on an active lifestyle, but will not take part in supervised training sessions and are not asked to do home-based exercise either.

Other: Control

Interventions

Exercise BEHAVIORAL

1 study arm doing continuous type exercise will be compared to 1 study arm doing high-intensity interval exercise, over the course of 12 weeks, respectively. Both arms will be compared to sedentary control patients.

Also known as: Home-based walking exercise

Continuous Exercise; High Intensity Interval Exercise

Control OTHER

For patients in the control group, general exercise recommendations (e.g. recommendations by the CDC suitable for all adult individuals) will be given, however, no training therapy intervention is done and no home-based walking exercise is required either.

Controls

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from non-small cell or small-cell lung cancer of any histologic subtype, irrespective of routine treatment regimen
• ECOG 0 or 1

You may not qualify if:

• Kachexia (BMI\<18.5)
• instable bone metastases
• orthopedic condition rendering the patient unable to ride a stationary bike
• any medical contraindication for exercise and training
• a living will against basic or advanced life support

Sponsors & Collaborators

• Medical University of Graz: lead
• Austrian Science Fund (FWF): collaborator

Study Sites (1)

Medical University of Graz

Graz, 8010, Austria

RECRUITING

Related Publications (6)

• Martin-Ruiz A, Fiuza-Luces C, Rincon-Castanedo C, Fernandez-Moreno D, Galvez BG, Martinez-Martinez E, Martin-Acosta P, Coronado MJ, Franco-Luzon L, Gonzalez-Murillo A, Ramirez M, Provencio M, Lucia A. Benefits of exercise and immunotherapy in a murine model of human non-small-cell lung carcinoma. Exerc Immunol Rev. 2020;26:100-115.

  PMID: 32139351 BACKGROUND

• Ungvari Z, Fekete M, Varga P, Munkacsy G, Fekete JT, Lehoczki A, Buda A, Kiss C, Ungvari A, Gyorffy B. Exercise and survival benefit in cancer patients: evidence from a comprehensive meta-analysis. Geroscience. 2025 Jun;47(3):5235-5255. doi: 10.1007/s11357-025-01647-0. Epub 2025 Apr 12.

  PMID: 40220151 BACKGROUND

• Winters-Stone KM, Neil SE, Campbell KL. Attention to principles of exercise training: a review of exercise studies for survivors of cancers other than breast. Br J Sports Med. 2014 Jun;48(12):987-95. doi: 10.1136/bjsports-2012-091732. Epub 2013 Jan 4.

  PMID: 23293010 BACKGROUND

• Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.

  PMID: 31626055 BACKGROUND

• Rezende LFM, Sa TH, Markozannes G, Rey-Lopez JP, Lee IM, Tsilidis KK, Ioannidis JPA, Eluf-Neto J. Physical activity and cancer: an umbrella review of the literature including 22 major anatomical sites and 770 000 cancer cases. Br J Sports Med. 2018 Jul;52(13):826-833. doi: 10.1136/bjsports-2017-098391. Epub 2017 Nov 16.

  PMID: 29146752 BACKGROUND

• Ashcraft KA, Peace RM, Betof AS, Dewhirst MW, Jones LW. Efficacy and Mechanisms of Aerobic Exercise on Cancer Initiation, Progression, and Metastasis: A Critical Systematic Review of In Vivo Preclinical Data. Cancer Res. 2016 Jul 15;76(14):4032-50. doi: 10.1158/0008-5472.CAN-16-0887. Epub 2016 Jul 5.

  PMID: 27381680 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Elisabeth Taucher, Dr. Dr.

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas Spielbüchler, MEd, BEd

CONTACT

+43 699 10558825; lukas.spielbuechler@medunigraz.at

Emine Betül Deniz, MSc

CONTACT

+43 676 4029105; emine.deniz@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 5, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 9, 2026

Record last verified: 2025-11

Locations

AU (1)