Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID05789485

Dose-response of Aerobic Training During Chemotherapy for Gastrointestinal Cancers

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-16

216

Participants Needed

8

Research Sites

6 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of different levels of aerobic exercise on reducing side effects in people receiving treatment for gastrointestinal cancers, including colorectal and esophago/gastric solid tumors. This phase 2 study aims to find safe, practical exercise doses that may improve how the body responds to chemotherapy and affect treatment outcomes like dose delivery and side effect management. The study also examines how exercise might influence treatment delays, reductions, or additional medication use. Participants will be randomly assigned to one of three groups with different weekly amounts of treadmill walking: 90, 150, or 300 minutes per week. The exercise sessions are individualized and supervised using TeleEx technology to track progress, following a non-linear schedule with rest and recovery. The exercise program runs throughout chemotherapy treatment, and staff will ensure participants have access to Wi-Fi and treadmills, providing tablets or local gym access if needed. During the study, participants will be assessed on their ability to complete planned chemotherapy doses, aiming for a ratio of delivered to planned treatment of 90% or higher over 5 years. Researchers will monitor adherence to the exercise program and evaluate physical responses using remote supervision. The total participation time varies with chemotherapy duration, and safety and treatment outcomes will be closely observed throughout the study period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Diagnosed with colorectal or esophago/gastric solid tumors confirmed by histology or standard imaging
  • Scheduled to receive neoadjuvant chemotherapy or chemotherapy for newly diagnosed metastatic disease
  • Performing 90 minutes or less of structured moderate-intensity or strenuous-intensity exercise per week
  • Willing to comply with all study-related procedures
  • Cleared for exercise participation via the Physical Activity Readiness Questionnaire
Not Eligible

You will not qualify if you...

  • Enrolled in any other lifestyle interventional investigational study unless approved by the principal investigator
  • Receiving treatment for any other invasive cancer diagnosis
  • Having mental impairment that prevents cooperation
  • Having any other condition or illness that makes participation unsafe or unsuitable according to the investigator

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Outpatient Treatment

Duration - Duration of chemotherapy treatment

Participants undergo aerobic training consisting of individualized treadmill walking up to 7 times per week during chemotherapy. Training dose is adjusted non-linearly with rest and recovery sessions throughout the treatment period and monitored remotely.

Weekly visits for monitoring and supervised aerobic training

Trial Site Locations

Total: 8 locations

1

Hartford Healthcare Alliance (Data Collection Only)

Hartford, Connecticut, United States, 06102

Actively Recruiting

2

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

3

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

4

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

5

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

6

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

7

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

8

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Rockville Centre, New York, United States, 11553

Actively Recruiting

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Research Team

J

Jessica Scott, PhD

A

Andrea Cercek, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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