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NCT Number: NCT05789485

A Study on the Effects of Exercise on Side Effects From Treatment 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hartford Healthcare Alliance (Data Collection Only), Hartford, Connecticut, United States

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About this study

Study staff will also confirm remote training feasibility including items such as access to Wi-Fi and a treadmill for the study duration. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

structured treadmill walking

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.

Primary outcomes

  1. proportion of patients achieving (ratio of delivered to planned treatment) RDI ≥ 90%

    Time frame: 5 years

    RDI (%) will be calculated as the ratio of delivered to planned dose intensity (delivered dose intensity/planned dose intensity).

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Cercek, MD

CONTACT

646-888-4189

Jessica Scott, PhD

CONTACT

[email protected]

646-888-8103

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Dose-response of Aerobic Training During Chemotherapy for Gastrointestinal Cancers

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 29, 2023
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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