Clinical trial NCT05789485: A Study on the Effects of Exercise on Side Effects From Treatment for Gastrointestinal Cancers
Official title: Dose-response of Aerobic Training During Neoadjuvant Chemotherapy for Gastrointestinal Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Gastrointestinal Cancer
Keywords: Exercise
22-164
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: proportion of patients achieving (ratio of delivered to planned treatment) RDI ≥ 90%
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Healthcare Alliance (Data Collection Only)
state: Connecticut
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Limited Protocol Activities)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Limited Protocol Activities)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jessica Scott, PhD
role: PRINCIPAL_INVESTIGATOR
References: