Trial Title:
A Study on the Effects of Exercise on Side Effects From Treatment for Gastrointestinal Cancers
NCT ID:
NCT05789485
Condition:
Gastrointestinal Cancer
Conditions: Official terms:
Gastrointestinal Neoplasms
Conditions: Keywords:
Exercise
22-164
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Investigator)
Masking description:
Patients and investigators will be blinded to results during study conduct.
Intervention:
Intervention type:
Behavioral
Intervention name:
structured treadmill walking
Description:
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.
Arm group label:
150 mins/wk
Arm group label:
300 mins/wk
Arm group label:
90 min/wk
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hartford Healthcare Alliance (Data Collection Only)
Address:
City:
Hartford
Zip:
06102
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jaykumar Thumar, MD
Phone:
860-676-7000
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Scott, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Scott, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Scott, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Scott, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Scott, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Scott, PhD
Phone:
646-888-8103
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Rockville Centre
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jessica Scott, PhD
Phone:
646-888-8103
Start date:
April 28, 2023
Completion date:
April 18, 2027
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05789485
http://www.mskcc.org/mskcc/html/44.cfm
