Status:
ACTIVE_NOT_RECRUITING
Study of the Effects of Pre-surgical Aerobic Exercise on Patients With Solid Tumors
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Vanderbilt University
Conditions:
Preoperative Aerobic Training
Solid Tumors
Eligibility:
All Genders
19+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to find the safest level of aerobic training for people about to undergo surgery for their cancer, and to learn what effects, if any, aerobic exercise has on these patient...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03813615
Start Date
January 21 2019
End Date
January 1 2026
Last Update
July 4 2025
Active Locations (8)
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1
University of California, Los Angeles (Data Analysis only)
Los Angeles, California, United States, 90095
2
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
3
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
4
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645