Study of the Effects of Pre-surgical Aerobic Exercise on Patients With Solid Tumors (NCT03813615) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Study of the Effects of Pre-surgical Aerobic Exercise on Patients With Solid Tumors
United States60 participantsStarted 2019-01-21
Plain-language 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 patients and the outcomes of their cancers. This part of the study (Phase 0) will evaluate the feasibility and quality of at-home exercise and assessment procedures and find out whether study participants are willing to practice continuous lifestyle monitoring using apps and electronic devices.
Phase 1a will compare the effects and feasibility of six different doses of aerobic exercise and will continue evaluating the quality of at-home study procedures, which includes the use of continuous lifestyle monitoring through apps and electronic devices.
In order to facilitate completion of the phase 1a component, we will backfill the 90, 225, and 300 mins/wk dosing cohorts with at least 4 patients in each dose cohort.
Who can participate
Age range19 Years
SexALL
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Inclusion Criteria:
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 evaluat…