A Study of Exercise Therapy in People With Solid Tumor Cancer

Neoadjuvant Exercise Therapy in Solid Tumors: A Phase 1b Dose Expansion Trial

The purpose of this study is to find out whether exercise therapy is an effective and safe treatment that causes few or mild side effects when done before standard surgery for solid tumor cancer. The researchers will also study whether the program is feasible (practical) by tracking how well participants follow the program.

Study Overview

• Status: Withdrawn
• Conditions: Solid Tumor Cancer
• Intervention / Treatment: Other: Exercise therapy

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
      • Contact: Lee Jones, PhD; Phone Number: 646-888-8103
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
      • Contact: Lee Jones, PhD; Phone Number: 646-888-8103
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
      • Contact: Lee Jones, PhD; Phone Number: 646-888-8103
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
      • Contact: Lee Jones, PhD; Phone Number: 646-888-8103
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
      • Contact: Lee Jones, PhD; Phone Number: 646-888-8103
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Lee Jones, PhD; Phone Number: 646-888-8103
      • Contact: Neil Iyengar, MD; Phone Number: 646-888-4714
    • Uniondale, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
      • Contact: David Jones, MD; Phone Number: 212-639-6428

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with histologically confirmed (on preoperative biopsy), resectable, treatment naïve cancer of one of the following types: head and neck, lung, renal, liver, colorectal, gastric, ovarian, melanoma, pancreas, or breast cancer.
• Age ≥18 years.
• An interval of ≥3 weeks until planned surgical resection; surgery will not be delayed to accommodate the minimum length of exercise therapy intervention in any circumstance.
• Measurable disease based on standard of care radiology scans or confirmation by the surgeon.
• Body weight ≤ 385 lbs (≤ 174 kg)
• Non-exercisers, defined as ≤60 minutes of moderate or vigorous exercise/week based on self-report using a validated survey.
• Cleared for moderate-intensity exercise therapy using the Physical Activity Readiness Questionnaire (PAR-Q)+ with screening clearance provided at the discretion of the PI/exercise physiologist.
• Willingness to comply with all study-related procedures

Exclusion Criteria:

• Distant metastases.
• Receiving any form of antitumor therapy.
• Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound the effect of exercise on study outcomes.
• Any other diagnosis of invasive cancer currently requiring active treatment.
• Any other condition (e.g., pregnancy) 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Exercise therapy; Exercise therapy will comprise individualized treadmill walking delivered up to 5 times weekly (over a 7-day period) to achieve a weekly cumulative dose of 225 minutes per week. The minimum treatment period will be 3 weeks. Exercise therapy will be administered via a patient-centric, decentralized platform: Digital Platform for Exercise (DPEx). DPEx will permit all study procedures to be conducted remotely in patients' homes.

Other: Exercise therapy; Patients will receive a study kit which includes a smart watch (for monitoring of mobility / lifestyle patterns), heart rate monitor, blood pressure cuff, scale, and e-tablet. Patients may receive a treadmill to perform exercise therapy sessions. The treadmills and study kits are MSK owned equipment that will be deployed to the patients' homes and returned at the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in Ki67 values	With at least one pretreatment (baseline) or postintervention measurement of Ki67 will be considered evaluable. To characterize biological activity of neoadjuvant exercise therapy as defined by the change in tumor cell proliferation marker (Ki67) evaluated in paired formalin-fixed paraffin embedded (FFPE) tumor samples obtained before (diagnostic biopsy) and after (surgical resection) exercise therapy. The biopsies will be collected as part of the standard medical care.	up to 3 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Lee 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): September 12, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Exercise Therapy; 24-232
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 24-232

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 beginning 12 months after publication and for up to 36 months post publication. 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.

Drug and device information, study documents

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