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Behavioural Intervention

Group A: Exercise Group for Colorectal Cancer

N/A

Waitlist Available

Led By Christina Dieli-Conwright, MPH, PhD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age at diagnosis 18-50 years

Patient diagnosed with early-stage or metastatic colon or rectal cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 1) and post-intervention (week 13)

Awards & highlights

Study Summary

This trial is a study where participants with early-stage or metastatic colorectal cancer will receive chemotherapy. The study will observe changes in the bacteria in their body, side effects from the chemotherapy, and how

Who is the study for?

This trial is for individuals with early-stage or metastatic colorectal cancer who are currently undergoing chemotherapy. Participants should be willing to either engage in an exercise program or be placed on a waitlist as part of the control group.Check my eligibility

What is being tested?

The COURAGE Trial is testing whether an exercise program can influence gut microbiome activity, reduce side effects from chemotherapy, and improve treatment outcomes for young-onset colorectal cancer patients compared to those not exercising.See study design

What are the potential side effects?

While the trial primarily involves an exercise program which typically has minimal risks, potential side effects may include usual exercise-related injuries or discomfort. Chemotherapy-related side effects will also be monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was diagnosed with my condition between the ages of 18 and 50.

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I have been diagnosed with early-stage or metastatic colon or rectal cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 1) and post-intervention (week 13)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 1) and post-intervention (week 13)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 1) and post-intervention (week 13) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gut Microbiome Genomes

Secondary outcome measures

Change in Chemotherapy Toxicity

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group A: Exercise GroupExperimental Treatment1 Intervention

42 participants will be enrolled using a permuted blocked design with varying block size and will complete study procedures as follows: Baseline in-office visit. Completion of exercise sessions 3x weekly. Post-intervention in-office visit.

Group II: Group B: Waitlist Control GroupActive Control1 Intervention

42 participants will be enrolled using a permuted blocked design with varying block size and will complete study procedures as follows: Baseline in-office visit. Participants will be asked to maintain baseline exercise behavior and/or usual, daily activities. Post-intervention in-office visit. Participants will be offered to participate in the exercise program upon the completion of post-intervention assessments.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Exercise Program

2016

Completed Phase 3

~4930

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

American Cancer Society, Inc.OTHER

224 Previous Clinical Trials

110,371 Total Patients Enrolled

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,864 Total Patients Enrolled

Christina Dieli-Conwright, MPH, PhDPrincipal InvestigatorDana-Farber Cancer Institute

1 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

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

Am I eligible to participate in this clinical trial?

"Individuals who wish to participate in this clinical trial must have a diagnosis of colorectal cancer and fall within the age range of 18 to 50. The total number of participants accepted into this study is limited to 84 individuals."

Answered by AI

Are patients currently eligible to participate in this ongoing medical study?

"According to the information available on clinicaltrials.gov, this particular trial is not currently seeking participants. The trial was initially posted on June 1st, 2024 and last updated on January 2nd, 2024. However, it's worth noting that there are currently a total of 1283 other active clinical trials actively recruiting patients at this time."

Answered by AI

Are individuals who are 75 years or older being actively sought for enrollment in this study?

"To participate in this clinical trial, individuals must be within the age range of 18 to 50. It is worth noting that there are currently 42 trials available for patients under the age of 18 and a total of 1266 trials targeting participants over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial

Christina Dieli-Conwright, PhD 2024. "Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy: The COURAGE Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06202183.