RecruitingPhase 2NCT05789485

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

216 participants

Start Date

Apr 28, 2023

Study Type

INTERVENTIONAL

Conditions

Gastrointestinal Cancer

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria4

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

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Interventions

BEHAVIORALstructured 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.