Gastrointestinal Cancer
Conditions
Keywords
Exercise, 22-164
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
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.
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
Patients and investigators will be blinded to results during study conduct.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
CONTACTJessica Scott, PhD
CONTACTAndrea Cercek, MD
PRINCIPAL_INVESTIGATORJessica Scott, PhD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed