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

Phase 2

Recruiting

• Conditions: Gastrointestinal Cancer
• Interventions: Behavioral: structured treadmill walking

• Registration Number: NCT05789485
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-29
• Study Start: 2023-04-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03
• Primary Completion: 2027-03-01
• Study Completion: 2027-04-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

• Aged ≥18 years

• Diagnosed with locally advanced 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

• 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 interventional investigational study, except interventions determined by the PI not to confound study outcomes
• Receiving treatment for any other diagnosis of invasive cancer
• Distant metastatic malignancy of any kind
• 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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
90 min/wk	structured treadmill walking	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.
150 mins/wk	structured treadmill walking	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.
300 mins/wk	structured treadmill walking	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.

Primary Outcome Measures

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

Trial Locations

Locations (8)

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

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities); 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities); 🇺🇸 Rockville Centre, New York, United States