An interventional study of Exercise in Non-Small Cell Lung Cancer, Aerobic Exercise and Immunotherapy, sponsored by Izmir Bakircay University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Izmir Bakircay University · Not applicable, Interventional, and Supportive care
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.
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.
6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.
This study's planned enrollment of 78 is above the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Izmir Bakircay University is the lead sponsor of 75 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
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
individuals assigned to the control group will receive information on the benefits of physical activity and exercise.
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
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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Before immunotherapy, week 12 and week 24
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.
Time frame: Before immunotherapy, week 12 and week 24
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.
Time frame: Before immunotherapy, week 12 and week 24
Body fat percentage
Body fat percentage will be evaluated via Tanita-BC-420 MA. It will be recorded as %(percentage).
Time frame: Before immunotherapy, week 12 and week 24
Skeletal Muscle Mass
Skeletal Muscle Mass will be evaluated via Tanita-BC-420 MA. It will be recorded as kilogram (kg).
Time frame: Before immunotherapy, week 12 and week 24
Fat free mass
Fat free mass will be evaluated via Tanita-BC-420 MA. It will be recorded as kilogram (kg).
Time frame: Before immunotherapy, week 12 and week 24
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.
Time frame: Before immunotherapy, week 12 and week 24
Analysis of Progression-free survival
Progression free survival will be performed during the study's timeframe.
Time frame: From enrollment until the end of the 24-month follow-up period
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared publicly or with other researchers due to participant privacy and confidentiality considerations.
Start is estimated for Jan 2027; primary completion for Mar 2029, 26 months later.
Of 305 non-industry interventional studies with no phase under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 123. This study's planned 26 months is below that.
Counting every sponsor, half of 320 studies reached it within 52 months; a quarter within 28 and three quarters within 123.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Izmir Bakircay University