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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - Any
Updated:3/13/2019
Start Date:January 21, 2019
End Date:January 2021
Contact:Lee W. Jones, PhD
Email:jonesl3@mskcc.org
Phone:646-888-8103

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


Inclusion Criteria:

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 ≤ 35

- 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 from the diagnostic biopsy to conduct
biological activity and DNA IMPACT panel sequencing

- All other eligibility criteria are identical to those described for Phase 0

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
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.
We found this trial at
8
sites
Commack, New York 11725
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Basking Ridge, New Jersey 07920
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Harrison, New York 10604
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Middletown, New Jersey 07748
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Montvale, New Jersey 07645
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Lee Jones, PhD
Phone: 646-888-8103
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Rockville Centre, New York 11570
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Uniondale, New York 11553
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Uniondale, NY
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