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
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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RECRUITING
PHASE2
216 participants
INTERVENTIONAL
2023-04-28
2027-04-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
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.
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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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
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
Countries
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Central Contacts
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Andrea Cercek, MD
Role: CONTACT
Facility Contacts
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Jaykumar Thumar, MD
Role: primary
Jessica Scott, PhD
Role: primary
Jessica Scott, PhD
Role: primary
Jessica Scott, PhD
Role: primary
Jessica Scott, PhD
Role: primary
Jessica Scott, PhD
Role: primary
Jessica Scott, PhD
Role: primary
Jessica Scott, PhD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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22-164
Identifier Type: -
Identifier Source: org_study_id
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