Summary

for people ages 19 years and up (full criteria)
at UCLA
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.

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)

  • Early-stage breast cancer having completed participation in IRB# 15-147 or diagnosed with the prespecified solid tumors: endometrial, breast and prostate cancer
  • Age >18 years
  • BMI ≤ 40
  • At least a 2-week window from study enrollment to scheduled surgical resection (for preoperative patients only)
  • Performing less than 90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluation by self report5
  • Access to an email address or MSK portal
  • 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 endometrial, breast or prostate cancer scheduled for surgery
  • Availability of adequate FFPE tumor slides or fresh tumor tissue, as appropriate
  • All other eligibility criteria are identical to those described for Phase 0

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 patients only)
  • Enrollment onto any other interventional investigational study
  • Men receiving GNRH agonists and antagonists as well as any antiandrogrens
  • Any neoadjuvant anticancer treatment of any kind
  • Any other current diagnosis of invasive cancer of any kind
  • 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
  • Memoral Sloan Kettering Basking Ridge (Consent and Follow-up) 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