Exercise and the tumor microenvironment in non-small cell lung cancer
Exercise and the Lung Cancer Tumor Microenvironment
This project will test whether a pre-surgery exercise program changes the tumor microenvironment and improves peri-operative outcomes for people with early-stage non-small cell lung cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Arizona Academic / other |
| Locations | 1 site (Tucson, Arizona) |
| Trial ID | NCT07216209 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls adults with early-stage non-small cell lung cancer who are scheduled for surgical resection and measures baseline physiologic fitness using VO2max, heart rate variability (HRV), and resting heart rate from clinical testing and wearable devices. Participants will undergo a targeted pre-operative exercise program (with or without medication) or usual care, and tumor tissue collected at resection will be analyzed for immune cell composition and molecular markers in the tumor microenvironment. Investigators will compare peri-operative and post-operative clinical outcomes, including complications and recovery, across patients with differing baseline physiologic states and after the exercise intervention. The aim is to link measurable physiologic metrics and pre-operative exercise to changes in tumor immune response and short-term surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults with early-stage non-small cell lung cancer scheduled for resection who are low risk for submaximal exercise testing per AHA/ACSM guidelines and who meet the study's BMI and health eligibility criteria.
Not a fit: Patients with advanced or metastatic disease, major comorbidities (such as autoimmune disease, recent stroke, HIV/hepatitis), BMI over 30, inability to safely exercise, or who require physician clearance on the ACSM-AHA screening are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, a targeted pre-operative exercise program could improve surgical recovery and boost anti-tumor immune activity, potentially lowering complications and future recurrence risk.
How similar studies have performed: Some prior studies show exercise improves systemic inflammation and pre-operative fitness, but direct evidence that pre-operative exercise alters the human lung tumor microenvironment is limited, making this a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tucson, Arizona
- University of Arizona Cancer Center — Tucson, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie Worrell, MD — University of Arizona
- Study coordinator: Stephanie Worrell, MD
- Email: sworrell@arizona.edu
- Phone: 5206267806
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.