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 range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.