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

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ClinicalTrials.gov Identifier: NCT03813615
Recruitment Status : Recruiting
First Posted : January 23, 2019
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Preoperative Aerobic Training Solid Tumors Behavioral: treadmill walking (Proof-of-Concept) Behavioral: treadmill walking Dose-Finding / Escalation Behavioral: treadmill walking Phase 1b: Dose-Expansion Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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 three cohorts of patients with prespecified solid malignancies.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Aerobic Training for Solid Tumors (PRESTO 1): A Phase 0/1a/b Digitized Clinical Trial
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

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 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.

Experimental: Phase 1a: Dose-Finding / Escalation
Individualized, progressive aerobic training consisting of treadmill walking ranging from a total of 150 mins/wk to 300 mins/wk delivered over 5 sessions/wk following a linear or non-linear dosing schedule for a minimum of 2 weeks.
Behavioral: treadmill walking Dose-Finding / Escalation
Three doses of aerobic training (150 mins/wk, 225 mins/wk & 300 mins/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 5 times weekly (over a 7-day period) for a minimum 2 weeks. Aerobic training treatment will be implemented & may be monitored using TeleEx. Pts 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 & 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.

Experimental: Phase 1b: Dose-Expansion
Individualized, progressive aerobic training consisting of treadmill walking delivered to achieve the RP2D identified in the phase 1a trial for a minimum of 2 weeks.
Behavioral: treadmill walking Phase 1b: Dose-Expansion
Individualized, progressive aerobic training consisting of treadmill walking delivered to achieve the recommended phase 2 dose (RP2D) identified in the phase 1a trial 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.




Primary Outcome Measures :
  1. identify the recommended dose of aerobic training [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 or fresh tumor tissue, as appropriate
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03813615


Contacts
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Contact: Lee W. Jones, PhD 646-888-8103 jonesl3@mskcc.org
Contact: David Hyman, MD 646-888-4544

Locations
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United States, California
University of California, Los Angeles (Data Analysis only) Recruiting
Los Angeles, California, United States, 90095
Contact: Paul C Boutros, PhD    310-794-7160      
United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent and Follow-up) Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Lee Jones, PhD    646-888-8103      
Memoral Sloan Kettering Monmouth (Consent and Follow-up) Recruiting
Middletown, New Jersey, United States, 07748
Contact: Lee Jones, PhD    646-888-8103      
Memorial Sloan Kettering Bergen (Consent and Follow-up) Recruiting
Montvale, New Jersey, United States, 07645
Contact: Lee Jones, PhD    646-888-8103      
United States, New York
Memorial Sloan Kettering Commack (Consent and Follow-up) Recruiting
Commack, New York, United States, 11725
Contact: Lee Jones, PhD    646-888-8103      
Memoral Sloan Kettering Westchester (Consent and Follow-up) Recruiting
Harrison, New York, United States, 10604
Contact: Lee Jones, PhD    646-888-8103      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Lee Jones, PhD    646-888-8103      
Contact: David Hyman, MD    646-888-4544      
Principal Investigator: Lee Jones, PhD         
Memorial Sloan Kettering Nassau (Consent and Follow-Up only) Recruiting
Uniondale, New York, United States, 11553
Contact: Lee Jones, PhD    646-888-8103      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Lee W. Jones, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03813615     History of Changes
Other Study ID Numbers: 18-534
First Posted: January 23, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Aerobic Training
18-534
Additional relevant MeSH terms:
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Neoplasms