Summary

Eligibility
for people ages 19 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

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.

Official Title

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

Keywords

Preoperative Aerobic Training Solid Tumors Aerobic Training 18-534 Neoplasms treadmill walking (Proof-of-Concept) treadmill walking Dose-Finding / Escalation treadmill walking Phase 1b: Dose-Expansion Pilot "Proof-of-Concept"

Eligibility

You can join if…

Open to people ages 19 years and up

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 lung and suspicious lung tissue from the standard of care diagnostic biopsy available for 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) and Phase 1b (Dose-Expansion)

  • Patients with operable untreated prostate cancer scheduled for surgery
  • At least a 2-week window from study enrollment to scheduled surgical resection
  • Age > 18 years
  • BMI </=40
  • 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

You CAN'T join if...

  • 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.

Locations

  • University of California, Los Angeles (Data Analysis only) accepting new patients
    Los Angeles California 90095 United States
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) accepting new patients
    Basking Ridge New Jersey 07920 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Memorial Sloan Kettering Cancer Center
Links
Memorial Sloan Kettering Cancer Center
ID
NCT03813615
Phase
Phase 1
Study Type
Interventional
Last Updated