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

Gastrointestinal Cancer Clinical Trial

Official title:

Dose-response of Aerobic Training During Neoadjuvant Chemotherapy for Gastrointestinal Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05789485
• Other study ID #: 22-164
• Status: Recruiting
• Phase: Phase 2
• Start date: April 28, 2023
• Est. completion date: April 18, 2027

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Jessica Scott, PhD
• Phone: 646-888-8103
• Email: scottj1[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: April 18, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Cancer
• Gastrointestinal Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)	Basking Ridge	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 Monmouth (Limited Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
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

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patients achieving (ratio of delivered to planned treatment) RDI = 90%	RDI (%) will be calculated as the ratio of delivered to planned dose intensity (delivered dose intensity/planned dose intensity).	5 years

External Links

•   Memorial Sloan Kettering Cancer Center