A Study on the Effects of Exercise on Side Effects From Treatment for Gastrointestinal Cancers

Dose-response of Aerobic Training During Chemotherapy for Gastrointestinal Cancers

The purpose of this study is to find the level of aerobic exercise (AT) that is practical, is safe, and has positive effects on the body that may reduce the side effects of therapy. The study will also look at the way the body responds to exercise and whether there are differences in treatment. This will include looking at the highest treatment dose participants receive, how many people stop, delay, or reduce the treatment, and whether additional medication is needed to treat side effects of therapy.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Cancer
• Intervention / Treatment: Behavioral: structured treadmill walking

Detailed Description

Study staff will also confirm remote training feasibility including items such as access to Wi-Fi and a treadmill for the study duration. During the feasibility assessment, if the participant is determined to not have access to Wi-Fi, we will offer a tablet with cellular capabilities. If patients do not have access to a treadmill, ExOnc staff may coordinate access to a fitness facility local to the participant, to facilitate treadmill access for the study duration. Fitness facility access will be provided through Wellhub, a service that allows use of nearby gyms and studios through a single app- based solution.

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jessica Scott, PhD; Phone Number: 646-888-8103; Email: scottj1@mskcc.org
• Study Contact Backup: Name: Andrea Cercek, MD; Phone Number: 646-888-4189

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Recruiting
      • Hartford Healthcare Alliance (Data collection only)
      • Contact: Jaykumar Thumar, MD; Phone Number: 860-676-7000
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
      • Contact: Jessica Scott, PhD; Phone Number: 646-888-8103
    • Middletown, New Jersey, United States, 07748
      • Recruiting
      • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
      • Contact: Jessica Scott, PhD; Phone Number: 646-888-8103
    • Montvale, New Jersey, United States, 07645
      • Recruiting
      • Memorial Sloan Kettering Bergen (Limited Protocol Activities)
      • Contact: Jessica Scott, PhD; Phone Number: 646-888-8103
  • New York
    • Commack, New York, United States, 11725
      • Recruiting
      • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
      • Contact: Jessica Scott, PhD; Phone Number: 646-888-8103
    • Harrison, New York, United States, 10604
      • Recruiting
      • Memorial Sloan Kettering Westchester (Limited Protocol Activities)
      • Contact: Jessica Scott, PhD; Phone Number: 646-888-8103
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center (All Protocol Activities)
      • Contact: Jessica Scott, PhD; Phone Number: 646-888-8103
    • Rockville Centre, New York, United States, 11553
      • Recruiting
      • Memorial Sloan Kettering Nassau (Limited Protocol Activities)
      • Contact: Jessica Scott, PhD; Phone Number: 646-888-8103

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged ≥18 years

• Diagnosed with colorectal or esophago/gastric solid tumors as defined by one of the following:

  • Histological confirmation
  • As per standard of care imaging
• Scheduled to receive neoadjuvant chemotherapy or chemotherapy for newly diagnosed metastatic disease
• Performing ≤90 minutes of structured moderate-intensity or strenuous-intensity exercise per week, as evaluated by self-report
• Willingness to comply with all study-related procedures
• Cleared for exercise participation as per screening clearance via the Physical Activity Readiness Questionnaire

Exclusion Criteria:

• Enrollment onto any other lifestyle interventional investigational study, except interventions determined by the PI not to confound study outcomes
• Receiving treatment for any other diagnosis of invasive cancer
• Mental impairment leading to inability to cooperate
• 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: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 90 min/wk; AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx.	Behavioral: structured treadmill walking; Three doses of AT (i.e., 90, 150, or 300 mins/week) will be tested. All doses will consist of individualized walking delivered up to 7 times per week delivered throughout treatment.
Experimental: 150 mins/wk; AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 2: 150 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx.	Behavioral: structured treadmill walking; Three doses of AT (i.e., 90, 150, or 300 mins/week) will be tested. All doses will consist of individualized walking delivered up to 7 times per week delivered throughout treatment.
Experimental: 300 mins/wk; AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 3: 300 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx.	Behavioral: structured treadmill walking; Three doses of AT (i.e., 90, 150, or 300 mins/week) will be tested. All doses will consist of individualized walking delivered up to 7 times per week delivered throughout treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
proportion of patients achieving (ratio of delivered to planned treatment) RDI ≥ 90%	RDI (%) will be calculated as the ratio of delivered to planned dose intensity (delivered dose intensity/planned dose intensity).	5 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Jessica Scott, 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): April 28, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 18, 2027

Study Registration Dates

• First Submitted: March 16, 2023
• First Submitted That Met QC Criteria: March 16, 2023
• First Posted (Actual): March 29, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; 22-164
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Behavior; Gastrointestinal Neoplasms; Motor Activity
• Other Study ID Numbers: 22-164

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
• product manufactured in and exported from the U.S.: No