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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Preoperative Aerobic Training Solid Tumors

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of California, Los Angeles (Data Analysis only), Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 criteria

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.

Treatment and study plan

treadmill walking (Proof-of-Concept)

Behavioral

Individualized, progressive aerobic training consisting of treadmill walking for a total of 150 mins/wk delivered over 5 sessions/wk following a linear dosing schedule for a minimum of 2 weeks. All aerobic training treatment will be implemented and may be monitored using TeleEx. Participants may also perform up to two aerobic training sessions per week in an unsupervised home-based setting. Patients will be provided with Appendix J - Unsupervised Home-Based Exercise Recording Form and Appendix K - Unsupervised Home-Based Exercise Instructions to record their sessions. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology. setting.

treadmill walking Dose-Finding / Escalation

Behavioral

Six doses of aerobic training ( 90mins/wk, 150 mins/wk, 225 mins/wk, 300 mins/wk & 450mins/wk) delivered following either a standard linear (i.e., each dose of exercise is performed at the same intensity & duration) or non-linear (i.e., exercise dose is continually altered & progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule 3 to 6 times weekly (over a 7-day period) for a minimum 2 weeks. Aerobic training treatment will be implemented & may be monitored using TeleEx. Patients may also perform up to three aerobic training sessions per week in an unsupervised home-based setting. Patients will be provided a plan for their unsupervised session(s) verbally or via Portal Secure Messaging (PSM), as appropriate.

Primary outcomes

identify the recommended dose of aerobic training

Time frame: 1 year

The relative dose intensity is defined as the ratio of completed to planned aerobic training dose continually assessed at the end of the intervention period.49 Hence, the maximal feasible dose is defined as the highest dose at which <30% of patients in a dosing cohort fail to achieve the target total cumulative relative dose intensity.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

Vanderbilt University

Registry information

Official study title

Preoperative Aerobic Training for Solid Tumors (PRESTO 1): A Phase 0/1a Digitized Clinical Trial

Important dates

Study start: 2019
Primary completion: 2027
Study completion: 2027
First posted: Jan 23, 2019
Registry last updated: Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Not Yet Recruiting