About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
EXERCISE TRAINING WITH OR WITHOUT MEDICATION
BehavioralAll 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.
Treatment groups
Trial outcomes
Primary outcomes
Tumor Microenvironment
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
Recurrence and Survival
Patients will be compared for evidence of recurrence and followed for long-term survival
Sponsors and contacts
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