AzTrials
AzTrials

Non-Small Cell Lung CancerEXIMPACTNCT07886359

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

A study testing Exercise in people with Non-Small Cell Lung Cancer and Aerobic Exercise, run by Izmir Bakircay University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
No sites listed yet
Study dates
4 Jan 2027to 15 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Gözde Kaya Uçar, Assist.Prof contact

+905432450621

gozde.kaya@bakircay.edu.tr

About this study

Official title: Investigation of the Effects of Supervised Aerobic Exercise Program on the Immune System and Tumor-Associated Biomarkers in Patients With Non-Small Cell Lung Cancer Receiving Immunotherapy: A Single-Blind, Randomized, Controlled Trial

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.

Read the detailed description

A total of 78 patients with NSCLC receiving active immunotherapy and meeting the predefined eligibility criteria will be enrolled. Participants assigned to the intervention group will perform supervised aerobic exercise on a cycle ergometer twice weekly for 24 weeks. Each session will consist of 5 minutes of warm-up, 30 minutes of aerobic exercise, and 5 minutes of cool-down. Exercise intensity will be prescribed based on estimated maximal oxygen consumption (VO₂max) and progressively increased from 60% during weeks 1-6 to 65% during weeks 7-12, 70% during weeks 13-18, and 75% during weeks 19-24. The exercise program will be implemented in accordance with the American College of Sports Medicine (ACSM) recommendations for exercise oncology. Assessments will be performed at baseline, 12 weeks, and at the end of 24 weeks. The primary outcomes will be immune system- and tumor microenvironment-related biomarkers which will be analyzed via ELISA system (CXCL9, CXCL11, CCL2, CCL5, IFN gamma and IL-10). Immune cells (NK cells, T and B lymphocytes, CD3+, CD4+, CD8+, CD19+, CD16/56+) will also be analyzed via flow-cytometry. Secondary outcomes will include handgrip strength, peripheral muscle strength, quality of life, fatigue, and cardiorespiratory capacity. Progression-free survival will also be evaluated as an exploratory clinical outcome. This study aims to provide prospective evidence regarding the potential immunomodulatory and tumor-related effects of structured aerobic exercise during active immunotherapy and to contribute to the development of individualized supportive exercise strategies for patients with NSCLC.

Being tested
Exercise
Keywords
Non-Small cell lung cancer, Exercise, Immunotherapy, Quality of life
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseOther

    Also called Aerobic stationary resistive cycle ergometer

    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.

Study groups in NCT07886359
Study groupRoleWhat they receive
ExerciseExperimentalA 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.
Receives: Other: Exercise
ControlNo interventionindividuals assigned to the control group will receive information on the benefits of physical activity and exercise.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Before immunotherapy, week 12 and week 24

  2. 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.

    Measured: Before immunotherapy, week 12 and week 24

  3. 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).

    Measured: Before immunotherapy, week 12 and week 24

  4. 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).

    Measured: Before immunotherapy, week 12 and week 24

  5. Cardiorespiratory endurance assessment

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

    Measured: Before immunotherapy, week 12 and week 24

Secondary outcomes (7)
  1. Assessment of Quality of Life

    Participants' quality of life will be assessed using the European Organization for Research and Treatment of Cancer to assess health-related quality of life in patients with lung cancer questionnaire (EORTC-QLQ-LC29), which was developed specifically for lung cancer patients by the European Organization for Research, Treatment and Cancer and has been proven to be valid and reliable. Higher scores indicate worse quality of life. The minimum and maximum values are ranged between 0 and 100.

    Measured: Before immunotherapy, week 12 and week 24

  2. Fatigue Assessment

    Fatigue will be assessed using the European Organization for Research and Treatment of Cancer to assess fatigue in patients with cancer (EORTC-QLQ-FA12).Higher scores indicate higher perceived fatigue. The minimum and maximum values are ranged between 0 and 100.

    Measured: Before immunotherapy, week 12 and week 24

  3. Body fat percentage

    Body fat percentage will be evaluated via Tanita-BC-420 MA. It will be recorded as %(percentage).

    Measured: Before immunotherapy, week 12 and week 24

  4. Skeletal Muscle Mass

    Skeletal Muscle Mass will be evaluated via Tanita-BC-420 MA. It will be recorded as kilogram (kg).

    Measured: Before immunotherapy, week 12 and week 24

  5. Fat free mass

    Fat free mass will be evaluated via Tanita-BC-420 MA. It will be recorded as kilogram (kg).

    Measured: Before immunotherapy, week 12 and week 24

  6. Mental status assessment

    Mental status assessment will be performed via Mini Mental State Examination test. It consists of five domains: orientation (10 points), registration (3 points), attention and calculation (5 points), recall (3 points), and language and visuospatial abilities (9 points). The total score ranges from 0 to 30, with higher scores indicating better cognitive function. Score interpretation is as follows: 24-30 indicates normal cognitive function; 18-23 indicates mild cognitive impairment; 10-17 indicates moderate cognitive impairment; and 0-9 indicates severe cognitive impairment.

    Measured: Before immunotherapy, week 12 and week 24

  7. Analysis of Progression-free survival

    Progression free survival will be performed during the study's timeframe.

    Measured: From enrollment until the end of the 24-month follow-up period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2026
  2. Study start4 Jan 2027 (estimated)
  3. Primary completion15 Mar 2029 (estimated)
  4. Study completion15 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A Single-Blind Randomized Controlled Trial
Masking
Single blind
Who is masked
Investigator
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07886359
Sponsor's protocol ID
BakircayU-nSCLC
Other IDs
226S466
Acronym
EXIMPACT
Status last verified
Oct 2026
First submitted
8 Oct 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared publicly or with other researchers due to participant privacy and confidentiality considerations.

Publications

  • 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.

    PubMed 41517582
  • 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.

    PubMed 37876940
  • 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.

    PubMed 34336101
  • 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.

    PubMed 25800229
  • 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.

    PubMed 38622609
  • 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.

    PubMed 32139351
  • 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.

    PubMed 38665847

Questions about this trial

What is this clinical trial studying?

A study testing Exercise in people with Non-Small Cell Lung Cancer and Aerobic Exercise, run by Izmir Bakircay University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alper Tuğral, Assoc.Prof (+902324930000 ext. 11259, alper.tugral@bakircay.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Analysis of Serum Biomarkers (Serum CXCL9,CXCL11,CCL2,CCL5,IFN-γ,IL-10 concentration) (time frame: Before immunotherapy, week 12 and week 24). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07886359, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in