Effects of exercise on side effects from gastrointestinal cancer treatment
Dose-response of Aerobic Training During Chemotherapy for Gastrointestinal Cancers
This study is testing whether a safe amount of treadmill walking can help people undergoing treatment for gastrointestinal cancer feel better and manage side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Hartford, Connecticut and 7 other locations) |
| Trial ID | NCT05789485 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the practical and safe levels of aerobic exercise that can positively impact patients undergoing treatment for gastrointestinal cancers. It will assess how structured treadmill walking influences the side effects of therapy and the body's response to exercise. The research will also evaluate treatment adherence, including the highest doses received and the need for additional medications to manage side effects. Participants will be closely monitored to ensure compliance with study procedures and exercise safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with locally advanced colorectal or esophago/gastric solid tumors who are scheduled to receive neoadjuvant chemotherapy.
Not a fit: Patients with distant metastatic malignancies or those receiving treatment for other invasive cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help reduce the side effects of cancer treatment, improving the quality of life for patients.
How similar studies have performed: Other studies have shown positive outcomes with exercise interventions in cancer treatment, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hartford, Connecticut and 7 other locations
- Hartford Healthcare Alliance (Data Collection Only) — Hartford, Connecticut, United States (Recruiting)
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Rockville Centre, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jessica Scott, PhD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Jessica Scott, PhD
- Email: scottj1@mskcc.org
- Phone: 646-888-8103
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.