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Recruiting NCT05789485

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

Phase II Interventional Gastrointestinal Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: structured treadmill walking.
Who it may be relevant to
Registry conditions: Gastrointestinal Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Dose-response of Aerobic Training During Chemotherapy for Gastrointestinal Cancers

Overview

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

  • 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.

Primary outcome measures

  • proportion of patients achieving (ratio of delivered to planned treatment) RDI ≥ 90% [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

United States · 8 centers
  • Hartford Healthcare Alliance (Data Collection Only) — Hartford
  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Rockville Centre

Identifiers

NCT: NCT05789485 · 22-164

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗