Pre-surgical Aerobic Exercise for Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byLee W. Jones, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Lee W. Jones, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults over 18 with a BMI ≤ 40 who have been diagnosed with early-stage breast, endometrial, or prostate cancer and are scheduled for surgery. They should not be doing more than minimal structured exercise weekly and must be willing to follow study procedures including at-home exercise and lifestyle monitoring.

Inclusion Criteria

- If BMI >40, patients may be eligible, at the discretion of the PI

I have prostate cancer that has not been treated yet, but I am scheduled for surgery.

- 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.

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Exclusion Criteria

I am a man taking hormone therapy for cancer.

Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation.

I am not part of any other clinical trials that could affect this study's results, except those approved by the study leader.

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Treatment Details

Interventions

Treadmill Walking (Behavioural Intervention)

Trial OverviewThe study tests different levels of pre-surgical aerobic exercise (treadmill walking) on patients with solid tumors. It aims to determine the safest exercise dose and its effects on patient health and cancer outcomes using apps and devices for continuous monitoring.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Pilot "Proof-of-Concept"Experimental Treatment1 Intervention

Individualized, progressive aerobic training consisting of treadmill walking for a total of 150 mins/wk delivered over 5 sessions/wk following a linear (breast, prostate, and endometrial) or non-linear (lung) dosing schedule for a minimum of 2 weeks.

Group II: Phase 1a: Dose-Finding / EscalationExperimental Treatment1 Intervention

Individualized, progressive aerobic training consisting of treadmill walking ranging from a total of 90 mins/wk to 450 mins/wk delivered over 3 to 7 sessions/wk following a linear or non-linear dosing schedule for a minimum of 2 weeks. If a patient is temporarily unable to complete supervised sessions as a result of unforeseen circumstances, patients may be assigned low intensity unsupervised training sessions per EP/PI discretion.