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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 belowSelect...
I have finished my chemotherapy treatments.
Select...
I am 18 years old or older.
Select...
My colorectal cancer is confirmed and is at stage I, II, or III.
Select...
I have had surgery to remove a tumor.
Select...
I do not have any major surgeries planned during the study.
Select...
I have finished any required radiotherapy.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My current weight is 181 kg or more.
Select...
I am not willing or able to be assigned to a treatment by chance.
Select...
My colon cancer has spread to other parts of my body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks
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
180,072 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,941 Total Patients Enrolled
Justin C Brown, Ph.D.Principal InvestigatorPennington Biomedical Research Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have finished my chemotherapy treatments.I am 18 years old or older.My current weight is 181 kg or more.My colorectal cancer is confirmed and is at stage I, II, or III.I am not willing or able to be assigned to a treatment by chance.My colon cancer has spread to other parts of my body.I have had surgery to remove a tumor.I do not have any major surgeries planned during the study.I have finished any required radiotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Aerobic Exercise
- Group 2: Control
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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