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

NCT ID: NCT05789485

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-28

Study Completion Date

2027-04-18

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gastrointestinal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators
Patients and investigators will be blinded to results during study conduct.

Study Groups

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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.

Group Type EXPERIMENTAL

structured treadmill walking

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

structured treadmill walking

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

structured treadmill walking

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessica Scott, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Hartford Healthcare Alliance (Data Collection Only)

Hartford, Connecticut, United States

Site Status RECRUITING

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Site Status RECRUITING

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Rockville Centre, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica Scott, PhD

Role: CONTACT

646-888-8103

Andrea Cercek, MD

Role: CONTACT

646-888-4189

Facility Contacts

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Jaykumar Thumar, MD

Role: primary

860-676-7000

Jessica Scott, PhD

Role: primary

646-888-8103

Jessica Scott, PhD

Role: primary

646-888-8103

Jessica Scott, PhD

Role: primary

646-888-8103

Jessica Scott, PhD

Role: primary

646-888-8103

Jessica Scott, PhD

Role: primary

646-888-8103

Jessica Scott, PhD

Role: primary

646-888-8103

Jessica Scott, PhD

Role: primary

646-888-8103

Related Links

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http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

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22-164

Identifier Type: -

Identifier Source: org_study_id

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