NCT03813615

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
7mo left

Started Jan 2019

Longer than P75 for early_phase_1

Geographic Reach
1 country

8 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Jan 2019Jan 2027

First Submitted

Initial submission to the registry

January 21, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

January 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 23, 2019

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

8 years

First QC Date

January 21, 2019

Last Update Submit

February 2, 2026

Conditions

Preoperative Aerobic TrainingSolid Tumors

Keywords

Aerobic Training18-534

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Pilot "Proof-of-Concept"

EXPERIMENTAL

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)

Phase 1a: Dose-Finding / Escalation

EXPERIMENTAL

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

Interventions

treadmill walking (Proof-of-Concept)BEHAVIORAL

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.

Pilot "Proof-of-Concept"
treadmill walking Dose-Finding / EscalationBEHAVIORAL

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.

Phase 1a: Dose-Finding / Escalation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • +6 more criteria

You may not qualify 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of California, Los Angeles (Data Analysis only)

Los Angeles, California, 90095, United States

Location

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553, United States

Location

Related Publications (1)

  • Jones LW, Moskowitz CS, Lee CP, Fickera GA, Chun SS, Michalski MG, Stoeckel K, Underwood WP, Lavery JA, Bhanot U, Linkov I, Dang CT, Ehdaie B, Laudone VP, Eastham JA, Collins A, Sheerin PT, Liu LY, Eng SE, Boutros PC. Neoadjuvant Exercise Therapy in Prostate Cancer: A Phase 1, Decentralized Nonrandomized ControlledTrial. JAMA Oncol. 2024 Sep 1;10(9):1187-1194. doi: 10.1001/jamaoncol.2024.2156.

    PMID: 39023900DERIVED

Related Links

Study Officials

  • Jessica Scott, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2019

First Posted

January 23, 2019

Study Start

January 21, 2019

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

February 4, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
SAP, ICF

Locations

US(8)