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Exercise for Colorectal Cancer Side Effects

Phase 2
Recruiting
Led By Jessica Scott, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will look at the role of exercise in reducing side effects of TNT, and how people's bodies respond to different levels of exercise.

Who is the study for?
This trial is for adults over 18 with locally advanced rectal cancer who do less than 90 minutes of moderate to strenuous exercise weekly. They must be scheduled for TNT (total neoadjuvant therapy) and cleared for exercise. People can't join if they're in another study, have distant metastatic cancer, are treated for another invasive cancer, or have mental impairments.
What is being tested?
The study tests the effects of structured treadmill walking as a form of aerobic exercise on reducing side effects from colorectal cancer treatment. It aims to determine a safe and practical level of activity that improves treatment responses and reduces the need for additional medication.
What are the potential side effects?
Since this trial involves structured treadmill walking, potential side effects may include typical exercise-related issues such as muscle soreness, fatigue, joint pain or injury risk. However, these are generally mild compared to drug treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
proportion of patients achieving (ratio of delivered to planned treatment) RDI ≥ 90%

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: 90 min/wkExperimental Treatment1 Intervention
AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx.
Group II: 300 mins/wkExperimental Treatment1 Intervention
AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx.
Group III: 150 mins/wkExperimental Treatment1 Intervention
AT will consist of individualized walking delivered up to 7 times per week to achieve a cumulative total duration of: Arm 1: 90 min/wk. AT therapy within each arm will follow a non-linear (i.e., AT dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule delivered during chemotherapy. Supervised AT will be monitored using TeleEx.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,979 Previous Clinical Trials
599,862 Total Patients Enrolled
Jessica Scott, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
6 Previous Clinical Trials
624 Total Patients Enrolled

Media Library

300 mins/wk Clinical Trial Eligibility Overview. Trial Name: NCT05789485 — Phase 2
Gastrointestinal Cancer Research Study Groups: 300 mins/wk, 90 min/wk, 150 mins/wk
Gastrointestinal Cancer Clinical Trial 2023: 300 mins/wk Highlights & Side Effects. Trial Name: NCT05789485 — Phase 2
300 mins/wk 2023 Treatment Timeline for Medical Study. Trial Name: NCT05789485 — Phase 2
~122 spots leftby Mar 2027
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