Recruiting
Phase 2

Exercise

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT05789485

Conditions

Gastrointestinal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

structured treadmill walking

Study Details

Brief summary:

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.

Conditions

Gastrointestinal Cancer

Study ID

NCT05789485

Start date

Apr 28, 2023

Status verified date

Aug, 2026

Completion date

Apr 18, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

216 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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.

Primary outcome measure

  • proportion of patients achieving (ratio of delivered to planned treatment) RDI ≥ 90% [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Jessica Scott, PhD

646-888-8103scottj1@mskcc.org

Andrea Cercek, MD

646-888-4189

Locations

Hartford Healthcare Alliance (Data Collection Only)

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Jaykumar Thumar, MD

(860) 676-7000

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Jessica Scott, PhD

646-888-8103

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Jessica Scott, PhD

646-888-8103

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Jessica Scott, PhD

646-888-8103

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Jessica Scott, PhD

646-888-8103

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Jessica Scott, PhD

646-888-8103

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Jessica Scott, PhD

646-888-8103

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Jessica Scott, PhD

646-888-8103

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

  • Exercise
  • 22-164

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-08-25.