Clinical trial · Interventional
The Impact of Exercise on the Tumor Microenvironment in Patients With Lung Cancer
Exercise and the Lung Cancer Tumor Microenvironment
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
There is increased interest and knowledge about the lung cancer tumor microenvironment (TME). Investigators hypothesize that patients with better baseline physiologic health will have better post-operative outcomes and that strenuous exercise will alter the TME and genetic make-up of the tumor, improving the tumor immune response. Investigators aim to identify the peri-operative and clinical outcomes that differ based on pre-operative VO2max, HRV and resting heart rate following resection of early-stage lung cancer. The physiologic states that are individual and measurable with wearable devices include but are not limited to VO2max, heart rate variability (HRV), and average resting heart rate. Investgators hypothesize that a patient's pre-operative physiologic function with higher VO2max, HRV and lower resting heart rate will be associated with improved peri-operative and post-operative outcomes. Second, investigators will compare alterations in TME based on targeted pre-operative exercise (60-80% of their VO2 max for 75min/week x2 weeks) compared to normal activity adults following resection of early-stage lung cancer. Investigators hypothesize that strenuous exercise in the pre-operative period will impact the TME by increasing levels of cytokines.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer - Non Small Cell | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATION | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Exercise arm
- description
- All patients will be offered a lab exercise regimen. For completion of Aim 2, only three or four visits are necessary, amounting to approximately 4 hours of the patient's time. The initial visit will be for pre-exercise screening. If the patient is deemed healthy enough to participate, an exercise test to determine the ventilatory threshold of the participant will be conducted and the VO2 determined. In the subsequent visits, the patient will perform exercise for 30 minutes at 15% above the volunteer's ventilatory threshold. Ideally, the patients will be able to complete a minimum of three sessions prior to surgery.
- interventionNames
- Behavioral: EXERCISE TRAINING WITH OR WITHOUT MEDICATION
Primary outcomes (1)
- measure
- Tumor Microenvironment
- timeFrame
- Baseline, Perioperative, up to 24 months
- description
- Lung cancer specimens will be collected from all patients at the time of surgery. Investigators will perform real-time PCR to identify levels of PDL-1
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * lung cancer * low risk for submaximal exercise testing in accordance with the risk stratification guidelines published by the American Heart Association and the American College of Sports Medicine (AHA/ACSM criteria). Exclusion Criteria: * younger than 18 years of age * select a condition on the ACSM-AHA pre-exercise screening questionnaire indicating that physician approval is required prior to exercise * body mass index of \>30 kg/m2 * waist girth of \>102cm for men and \>88cm for women * have chronic/debilitating arthritis * have been bedridden in the past three months * have common illness (i.e. colds) within the past 6-weeks * HIV * hepatitis * history of stroke * major affective disorder * autoimmune disease * pregnancy or are breast-feeding * history of severe anaphylactic reaction to an allergen * present with more than one of the following CVD risk factors: family history of myocardial infarction, coronary revascularization, or sudden death before 55 years of age in father or other male first-degree relative or before 65 years of age in mother or other female first-degree relative
References
Publications (8)
- BACKGROUNDTan Z, Xue H, Sun Y, Zhang C, Song Y, Qi Y. The Role of Tumor Inflammatory Microenvironment in Lung Cancer. Front Pharmacol. 2021 May 17;12:688625. doi: 10.3389/fphar.2021.688625. eCollection 2021. PMID 34079469
- BACKGROUNDIto M, Ishii G, Nagai K, Maeda R, Nakano Y, Ochiai A. Prognostic impact of cancer-associated stromal cells in patients with stage I lung adenocarcinoma. Chest. 2012 Jul;142(1):151-158. doi: 10.1378/chest.11-2458. PMID 22302300
- BACKGROUNDHerbst RS, Soria JC, Kowanetz M, Fine GD, Hamid O, Gordon MS, Sosman JA, McDermott DF, Powderly JD, Gettinger SN, Kohrt HE, Horn L, Lawrence DP, Rost S, Leabman M, Xiao Y, Mokatrin A, Koeppen H, Hegde PS, Mellman I, Chen DS, Hodi FS. Predictive correlates of response to the anti-PD-L1 antibody MPDL3280A in cancer patients. Nature. 2014 Nov 27;515(7528):563-7. doi: 10.1038/nature14011. PMID 25428504
- BACKGROUNDZhang L, Chen Y, Wang H, Xu Z, Wang Y, Li S, Liu J, Chen Y, Luo H, Wu L, Yang Y, Zhang H, Peng H. Massive PD-L1 and CD8 double positive TILs characterize an immunosuppressive microenvironment with high mutational burden in lung cancer. J Immunother Cancer. 2021 Jun;9(6):e002356. doi: 10.1136/jitc-2021-002356. PMID 34140315
- BACKGROUNDRosero ID, Ramirez-Velez R, Lucia A, Martinez-Velilla N, Santos-Lozano A, Valenzuela PL, Morilla I, Izquierdo M. Systematic Review and Meta-Analysis of Randomized, Controlled Trials on Preoperative Physical Exercise Interventions in Patients with Non-Small-Cell Lung Cancer. Cancers (Basel). 2019 Jul 5;11(7):944. doi: 10.3390/cancers11070944. PMID 31284372
- BACKGROUNDSimpson RJ, Campbell JP, Gleeson M, Kruger K, Nieman DC, Pyne DB, Turner JE, Walsh NP. Can exercise affect immune function to increase susceptibility to infection? Exerc Immunol Rev. 2020;26:8-22. PMID 32139352
- BACKGROUNDPuchelle E, Zahm JM, Tournier JM, Coraux C. Airway epithelial repair, regeneration, and remodeling after injury in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2006 Nov;3(8):726-33. doi: 10.1513/pats.200605-126SF.