The Impact of Exercise on the Tumor Microenvironment in Patients With Lung Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Arizona

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • EXERCISE TRAINING WITH OR WITHOUT MEDICATION

    Behavioral

    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.

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: Exercise armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline, Perioperative, up to 24 months

Secondary outcomes

1

Recurrence and Survival

Patients will be compared for evidence of recurrence and followed for long-term survival

Time frame
Baseline, Perioperative, up to 24 months

Other outcomes

Sponsors and contacts

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