Effects of Supervised Aerobic Exercise on Biomarkers in Patients With nSCLC Receiving Immunotherapy

NCT07886359 | Not Yet Recruiting

• 2 other identifiers: BakircayU-nSCLC226S466
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

Exercise is increasingly recognized as a supportive intervention in oncology and may influence systemic inflammation, immune regulation, physical function, and the tumor microenvironment among patients with non-small cell lung cancer. The EXIMPACT trial will investigate the effects of a supervised aerobic exercise program on immune system- and tumor microenvironment-related biomarkers in patients with NSCLC receiving active immunotherapy. Although immunotherapy has improved outcomes for patients with NSCLC, factors influencing treatment response and strategies to enhance treatment efficacy remain under investigation.

Conditions

Biomarker; Non-Small Cell Lung Cancer; Aerobic Exercise; Immunotherapy; Tumor Microenvironment; Handgrip Strength; Quality of Life

Keywords

Non-Small cell lung cancer; Exercise; Immunotherapy; Quality of life

Outcome Measures

Primary Outcomes (5)

• Analysis of Serum Biomarkers (Serum CXCL9,CXCL11,CCL2,CCL5,IFN-γ,IL-10 concentration)

  Serum CXCL9,CXCL11,CCL2,CCL5,IFN-γ,IL-10 concentrations will be measured using ELISA. Results will be expressed in pg/mL.

  Before immunotherapy, week 12 and week 24

• Assesment of Absolute CD3+ , CD4+ , CD8+ , CD19+ T-lymphocyte counts, CD16/56+ Natural Killer cells

  Absolute CD3+ , CD4+ , CD8+ , CD19+ T-lymphocyte counts, CD16/56+ Natural Killer cells will be assessed by flow cytometry using the BD Multitest™ 6-Color TBNK reagent and BD FACSLyric™ flow cytometer. Absolute counts will be calculated using a dual-platform approach incorporating routine complete blood count data. Results will be expressed in cells/µL.

  Before immunotherapy, week 12 and week 24

• Analysis of Handgrip Strength

  Handgrip strength will be evaluated via hand dynamometer while one is upright seated in an armless chair, elbow flexed 90 degree and forearm positioned at midprone. Three repetitions will be collected, the mean of them will be recorded. Handgrip strength will be recorded as kilogram (kg).

  Before immunotherapy, week 12 and week 24

• Peripheral muscle strength

  Participants' peripheral muscle strength will be assessed using a digital hand dynamometer (LaFayette Manual Muscle Tester) to measure knee extension of the quadriceps femoris muscle, with three repetitions on each side; measurements will be recorded in Newtons. Peripheral muscle strength will be recorded as Newton (N).

  Before immunotherapy, week 12 and week 24

• Cardiorespiratory endurance assessment

  Cardiorespiratory endurance will be evaluated via the six minute walk test and total walking distance will be recorded in meters (m).

  Before immunotherapy, week 12 and week 24

Secondary Outcomes (7)

• Assessment of Quality of Life

  Before immunotherapy, week 12 and week 24

• Fatigue Assessment

  Before immunotherapy, week 12 and week 24

• Body fat percentage

  Before immunotherapy, week 12 and week 24

• Skeletal Muscle Mass

  Before immunotherapy, week 12 and week 24

• Fat free mass

  Before immunotherapy, week 12 and week 24

Study Arms (2)

Exercise

EXPERIMENTAL

A resistance-based supervised aerobic exercise program using a stationary cycle ergometer will be conducted twice a week for a total of 24 weeks. Each session will last 40 minutes, consisting of a 5-minute warm-up, a 30-minute workout, and a 5-minute cool-down.

Other: Exercise

Control

NO INTERVENTION

individuals assigned to the control group will receive information on the benefits of physical activity and exercise.

Interventions

Exercise OTHER

A resistance-based aerobic exercise program using a stationary bike will be implemented twice a week for a total of 24 weeks. Each session will last a total of 40 minutes, consisting of a 5-minute warm-up, a 30-minute exercise period, and a 5-minute cool-down. The moderate-intensity range (60-75% of VO₂max) is defined as the optimal range that is both safe and conducive to physiological adaptation. Exercise intensity will initially be determined based on the estimated VO2max value calculated from each individual's 6-Minute Walk Test result. Based on the clinical value obtained, the initial exercise intensity will be set, and during exercise, heart rate reserve (Karvonen formula) and the Borg Perceived Exertion Scale (target range of 11-14) will be monitored together; if the intensity becomes intolerable, it will be reduced by 5%. If an immune-related adverse event occurs, the exercise will be temporarily suspended.

Also known as: Aerobic stationary resistive cycle ergometer

Exercise

Eligibility Criteria

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

You may qualify if:

• Be willing to participate in the study
• Have been diagnosed with nSCLC and be a candidate for immunotherapy
• Having ability to read, write, and communicate in Turkish or English

You may not qualify if:

• Presence of orthopedic (nerve compression, joint deformity, nerve damage, etc.) and/or neurological (ataxia, history of cerebrovascular events, etc.) deficits or disabilities that would prevent the patient from exercising
• A history of distant metastases diagnosed by a physician and confirmed by imaging studies
• Presence of mental and/or cognitive impairment
• Use of antiepileptic medications
• Pregnancy
• A tendency to bleed (thrombocytopenia)
• Diagnosis of small cell lung cancer

Sponsors & Collaborators

• Izmir Bakircay University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Related Publications (7)

• Gouez M, Perol O, Pialoux V, Avrillon V, Boussageon M, Decroisette C, Delrieu L, El Hajj H, Fournier B, Gille R, His M, Mastroianni B, Swalduz A, Perol M, Fervers B. Feasibility and Preliminary Efficacy of Aerobic Acute Exercise Prior to Immunotherapy and Chemotherapy Infusion in Patients with Metastatic Non-Small Cell Lung Cancer: A Randomized Controlled Trial. J Clin Med. 2026 Jan 1;15(1):334. doi: 10.3390/jcm15010334.

  PMID: 41517582 BACKGROUND

• Yan H, Jiang A, Huang Y, Zhang J, Yang W, Zhang W, Liu T. Exercise sensitizes PD-1/PD-L1 immunotherapy as a hypoxia modulator in the tumor microenvironment of melanoma. Front Immunol. 2023 Oct 9;14:1265914. doi: 10.3389/fimmu.2023.1265914. eCollection 2023.

  PMID: 37876940 BACKGROUND

• Ramachandran S, Verma AK, Dev K, Goyal Y, Bhatt D, Alsahli MA, Rahmani AH, Almatroudi A, Almatroodi SA, Alrumaihi F, Khan NA. Role of Cytokines and Chemokines in NSCLC Immune Navigation and Proliferation. Oxid Med Cell Longev. 2021 Jul 16;2021:5563746. doi: 10.1155/2021/5563746. eCollection 2021.

  PMID: 34336101 BACKGROUND

• Quist M, Adamsen L, Rorth M, Laursen JH, Christensen KB, Langer SW. The Impact of a Multidimensional Exercise Intervention on Physical and Functional Capacity, Anxiety, and Depression in Patients With Advanced-Stage Lung Cancer Undergoing Chemotherapy. Integr Cancer Ther. 2015 Jul;14(4):341-9. doi: 10.1177/1534735415572887. Epub 2015 Mar 22.

  PMID: 25800229 BACKGROUND

• Miao SN, Chai MQ, Liu XY, Wei CY, Zhang CC, Sun NN, Fei QZ, Peng LL, Qiu H. Exercise accelerates recruitment of CD8+ T cell to promotes anti-tumor immunity in lung cancer via epinephrine. BMC Cancer. 2024 Apr 15;24(1):474. doi: 10.1186/s12885-024-12224-7.

  PMID: 38622609 BACKGROUND

• 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

• Liu J, Liu W, Wan Y, Mao W. Crosstalk between Exercise and Immunotherapy: Current Understanding and Future Directions. Research (Wash D C). 2024 Apr 25;7:0360. doi: 10.34133/research.0360. eCollection 2024.

  PMID: 38665847 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; 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

• Alper Tuğral, Assoc.Prof

  Izmir Bakircay University

  PRINCIPAL INVESTIGATOR

• Gözde Kaya Uçar, Assist.Prof

  Izmir Bakircay University

  STUDY CHAIR

• Murat Akyol, MD, Prof.

  Izmir Bakircay University

  STUDY CHAIR

• Melih Zeren, Assoc.Prof

  Izmir Bakircay University

  STUDY CHAIR

• Fatma D Arslan, MD, Prof.

  Izmir Bakircay University

  STUDY CHAIR

• Mutlu O Güçsav, MD

  Izmir Bakircay University

  STUDY CHAIR

• Rasime D Kılıçoğlu, MD

  Izmir City Hospital

  STUDY CHAIR

• Ezgisu Türker, PT

  Izmir Bakircay University

  STUDY CHAIR

Central Study Contacts

Alper Tuğral, Assoc.Prof

CONTACT

+902324930000; alper.tugral@bakircay.edu.tr

Gözde Kaya Uçar, Assist.Prof

CONTACT

+905432450621; gozde.kaya@bakircay.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Samples will be masked to investigators (responsible for biomarker assessment) whether they belong to intervention or control group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: A Single-Blind Randomized Controlled Trial

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 21, 2026
• Study Start (Estimated): January 4, 2027
• Primary Completion (Estimated): March 15, 2029
• Study Completion (Estimated): June 15, 2029
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share