Clinical trial NCT03813615: Study of the Effects of Pre-surgical Aerobic Exercise on Patients With Solid Tumors
Official title: Preoperative Aerobic Training for Solid Tumors (PRESTO 1): A Phase 0/1a Digitized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Preoperative Aerobic Training
Solid Tumors
Keywords: Aerobic Training
18-534
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
First posted: 2019-01-23
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: This protocol is a single-center, open-label, phase 0 / 1 a/b study of preoperative aerobic training in patients with untreated solid tumors. This study design allows for the enrollment of patients with various types of cancer. This study will target patients with prespecified solid malignancies.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: identify the recommended dose of aerobic training
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles (Data Analysis only)
state: California
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Lee W. Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: