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Behavioural Intervention

Exercise for Colorectal Cancer

N/A

Recruiting

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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gut Microbiome Genomes

Secondary study objectives

Change in Chemotherapy Toxicity

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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