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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Solid Tumors; Preoperative Aerobic Training
• Intervention / Treatment: Behavioral: treadmill walking (Proof-of-Concept); Behavioral: treadmill walking Dose-Finding / Escalation

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Lee W. Jones, PhD; Phone Number: 646-888-8103; Email: jonesl3@mskcc.org
• Study Contact Backup: Name: Jessica Scott, PhD; Phone Number: 646-888-8093; Email: scottj1@mskcc.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles (Data Analysis only)
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
    • Montvale, New Jersey, United States, 07645
      • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Commack (Limited Protocol Activities)
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Nassau (Limited protocol activities)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilot "Proof-of-Concept"; 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.	Behavioral: treadmill walking (Proof-of-Concept); Individualized, progressive aerobic training consisting of treadmill walking for a total of 150 mins/wk delivered over 5 sessions/wk following a linear dosing schedule for a minimum of 2 weeks. All aerobic training treatment will be implemented and may be monitored using TeleEx. Participants may also perform up to two aerobic training sessions per week in an unsupervised home-based setting. Patients will be provided with Appendix J - Unsupervised Home-Based Exercise Recording Form and Appendix K - Unsupervised Home-Based Exercise Instructions to record their sessions. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology. setting.
Experimental: Phase 1a: Dose-Finding / Escalation; 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.	Behavioral: treadmill walking Dose-Finding / Escalation; Six doses of aerobic training ( 90mins/wk, 150 mins/wk, 225 mins/wk, 300 mins/wk & 450mins/wk) delivered following either a standard linear (i.e., each dose of exercise is performed at the same intensity & duration) or non-linear (i.e., exercise dose is continually altered & progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule 3 to 6 times weekly (over a 7-day period) for a minimum 2 weeks. Aerobic training treatment will be implemented & may be monitored using TeleEx. Patients may also perform up to three aerobic training sessions per week in an unsupervised home-based setting. Patients will be provided a plan for their unsupervised session(s) verbally or via Portal Secure Messaging (PSM), as appropriate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
identify the recommended dose of aerobic training	The relative dose intensity is defined as the ratio of completed to planned aerobic training dose continually assessed at the end of the intervention period.49 Hence, the maximal feasible dose is defined as the highest dose at which <30% of patients in a dosing cohort fail to achieve the target total cumulative relative dose intensity.	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Lee W. Jones, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2019
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: January 21, 2019
• First Submitted That Met QC Criteria: January 21, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): January 12, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Aerobic Training; 18-534
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 18-534

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No