Recruiting

Exercise & Tumor Microenvironment

Sponsor:

University of Arizona

Code:

NCT07216209

Conditions

Lung Cancer - Non Small Cell

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

Study Details

Brief summary:

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

Lung Cancer - Non Small Cell

Study ID

NCT07216209

Start date

Jan 13, 2026

Status verified date

Apr, 2026

Completion date

Jan 15, 2030

Anticipated

Primary completion date

Jan 15, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Exercise arm

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.

Interventions

EXERCISE TRAINING WITH OR WITHOUT MEDICATION

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.

Primary outcome measure

  • Tumor Microenvironment [ Time Frame: Baseline, Perioperative, up to 24 months ]

Central Contacts and Locations

Central contacts

Stephanie Worrell, MD

5206267806sworrell@arizona.edu

Melissa Landau

5206267806mlandau@surgery.arizona.edu

Locations

University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Stephanie Worrell, MD

520-626-7806sworrell@arizona.edu

Melissa Landau

5206267806mlandau@surgery.arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • exercise
  • tumor microenvironment
  • lung cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2026-04-21.