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Exercise for Colorectal Cancer (EXACT Trial)

N/A
Waitlist Available
Led By Justin C Brown, Ph.D.
Research Sponsored by Pennington Biomedical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Completed chemotherapy (if applicable)
Age ≥18 years
Must not have
Current body mass greater than or equal to 181 kg
Unable or unwilling to be randomized
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks

Summary

This trial will look at how exercise may help keep colorectal cancer from coming back in people who have finished treatment.

Who is the study for?
This trial is for adults over 18 who've finished treatment for stage I-III colorectal cancer and aren't very active, doing less than 90 minutes of moderate exercise a week. They can't be planning major surgery during the study or have other active cancers (except certain skin cancers), be in another weight loss or diet study, have metastatic colon cancer, weigh more than 181 kg, or have conditions that make exercising unsafe.
What is being tested?
The trial is testing if moderate-intensity aerobic exercise helps prevent colorectal cancer from coming back after treatment. Participants will either start an exercise program right away or be put on a wait-list while researchers track their health outcomes.
What are the potential side effects?
Since this trial involves moderate exercise as the intervention, side effects might include typical workout-related issues like muscle soreness, fatigue, and risk of injury. The severity would vary based on individual fitness levels and adherence to safe exercise practices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have finished my chemotherapy treatments.
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I am 18 years old or older.
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My colorectal cancer is confirmed and is at stage I, II, or III.
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I have had surgery to remove a tumor.
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I do not have any major surgeries planned during the study.
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I have finished any required radiotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My current weight is 181 kg or more.
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I am not willing or able to be assigned to a treatment by chance.
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My colon cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
High Sensitivity C-Reactive Protein
Interleukin-6
Secondary study objectives
Circulating Tumor Cells
Insulin Resistance
Soluble Tumor Necrosis Factor-Alpha Receptor Two
Other study objectives
Fatty Acid Oxidation
Mitochondrial Respiration Rate
Tumor Fraction

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Aerobic ExerciseExperimental Treatment1 Intervention
Moderate-intensity aerobic exercise
Group II: ControlPlacebo Group1 Intervention
Wait-list control

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor
309 Previous Clinical Trials
179,858 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,027 Total Patients Enrolled
Justin C Brown, Ph.D.Principal InvestigatorPennington Biomedical Research Center

Media Library

Moderate-Intensity Aerobic Exercise Clinical Trial Eligibility Overview. Trial Name: NCT03975491 — N/A
Colorectal Cancer Research Study Groups: Aerobic Exercise, Control
Colorectal Cancer Clinical Trial 2023: Moderate-Intensity Aerobic Exercise Highlights & Side Effects. Trial Name: NCT03975491 — N/A
Moderate-Intensity Aerobic Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT03975491 — N/A
~9 spots leftby Dec 2025
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