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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

Study 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.Check my eligibility
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.See study design
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

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

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
1,936 Previous Clinical Trials
588,676 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
Colorectal Cancer Research Study Groups: 300 mins/wk, 90 min/wk, 150 mins/wk
Colorectal 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What possible risks might individuals face by engaging in 90 min/wk of activity?

"As this clinical trial is in its Phase 2, with only safety data available and no efficacy results, the Power team ranked 90 min/wk's safety as a score of 2."

Answered by AI

How many participants are currently accepted to partake in this clinical examination?

"Affirmative. Clinicaltrials.gov contains information that this trial is open to recruitment, beginning on March 7th 2023 and last modified on the 16th of the same month. This study looks for 216 volunteers from seven different healthcare centres."

Answered by AI

How many venues are actively administering this clinical experiment?

"Currently, this clinical trial has seven recruitment centres located in Middletown, Montvale, and Commack as well as four other sites. If you are interested in taking part, it is prudent to select the closest clinic so that travel demands can be kept at a minimum."

Answered by AI

Are there still vacancies open for participants in this trial?

"Affirmative. Clinicaltrials.gov data shows that the trial was initially posted on March 7th, 2023 and recently updated on 16th of the same month. This investigation is seeking 216 participants from seven different medical sites."

Answered by AI

Who else is applying?

What site did they apply to?
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study on the Effects of Exercise on Side Effects From Treatment for Colorectal Cancer
2023. "A Study on the Effects of Exercise on Side Effects From Treatment for Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05789485.
~144 spots leftby Mar 2027
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