Study of the Effects of Pre-surgical Aerobic Exercise on Patients With Solid Tumors

Open to people ages 19 years and up

Phase 0 (Proof-of-Concept)

• Patients with one of the following:
  • Early-stage breast cancer having completed participation in IRB# 15-147
  • Diagnosed with the prespecified solid tumors: endometrial, breast or prostate cancer
  • Underwent a diagnostic lung biopsy within 14 days prior to enrollment
  • Age >18 years
  • BMI ≤ 40
  • Has ≥ 20 mg of fresh normal lung and suspicious lung tissue from the standard of care diagnostic biopsy available for snap freezing and single-cell sequencing (lung patients only)
  • At least a 2-week window from study enrollment to scheduled surgical resection (patients with prespecified solid tumors only)
  • Performing less than 30 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluation by self report If > 30 minutes but less than 90 minutes, patients may be eligible, at the discretion of the PI.
  • Cleared for exercise participation as per screening clearance via PAR-Q+
  • Willingness to comply with all study-related procedures

Phase 1a (Dose-Finding/Escalation)

• Patients with operable untreated prostate cancer scheduled for surgery
• At least a 2-week window from study enrollment to scheduled surgical resection (patients with prespecified solid tumors only)
• Age > 18 years
• BMI </=40
• If BMI >40, patients may be eligible, at the discretion of the PI
• Performing </= 30 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluation by self report If > 30 minutes but less than 90 minutes, patients may be eligible, at the discretion of the PI.
• Cleared for exercise participation as per screening clearance via PAR-Q+
• Willingness to comply with all study-related procedures

• Use of any selective estrogen receptor modulator or aromatase inhibitor within 6 months of study entry, including, but not limited to: tamoxifen, raloxifene, arzoxifene, acolbifene, anastrozole, exemestane, and letrozole (for preoperative breast, endometrial, and prostate patients in Phase 0 only)
• Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound the effect of exercise on study outcomes
• Men receiving GNRH agonists and antagonists as well as any antiandrogrens
• Any neoadjuvant anticancer treatment of any kind for the cancer of interest
• Any history of systemic anticancer therapy
• Any other diagnosis of invasive cancer currently requiring active treatment
• Metastatic malignancy of any kind
• Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation.