Colon Cancer Clinical Trial

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

Summary

This research study is a randomized controlled trial that will observe changes in microbiome activity, changes in chemotherapy toxicity, and any changes in treatment outcomes between two groups of participants undergoing chemotherapy with either early-stage or metastatic colorectal cancer.

The names of the study groups involved in this study are:

Exercise
Waitlist Control

View Full Description

Full Description

This research study is a single-center, two-armed, randomized controlled trial that will observe changes in microbiome activity, changes in chemotherapy toxicity, and any changes in treatment outcomes between two groups of participants undergoing chemotherapy with either early-stage or metastatic colorectal cancer. Participants will be randomly assigned to one of two groups: Group A: Exercise group (EXE) vs. Group B: Waitlist control group (WC). Randomization means that a participant will be placed into one of the study groups by chance.

The research study procedures include screening for eligibility, blood tests, stool samples, and survey questionnaires.

Participation in this research study will last up to 6 months.

It is expected that about 84 people will take part in this research study.

The American Cancer Society is providing funding for this research study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patient diagnosed with early-stage or metastatic colon or rectal cancer
Age at diagnosis 18-50 years; due to the specificity of the study question those outside the age bracket will not be included
No plans for major surgical intervention at the time of recruitment for a minimum of 12 weeks (i.e. study period; placement of port a cath is allowed)
No plans for radiation therapy at the time of recruitment for a minimum of 12 weeks
Within the first four weeks of starting chemotherapy
Participate in less than or equal to 90 minutes of moderate-to-vigorous exercise per week
Medical clearance to perform exercise intervention and testing by their treating oncologist
No uncontrolled medical conditions that could be exacerbated with exercise
Ability to communicate and complete written forms in English
Ability to understand and the willingness to sign informed consent prior to any study-related procedures
Willing to travel to DFCI for necessary data collection

Exclusion Criteria:

Participate in more than 90 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described exercise intervention, where additional exercise done regularly will contaminate the intervention effects.
Unstable comorbidities that prevent participation in moderate-to-vigorous intensity exercise. Patients with unstable comorbidities may develop unexpected adverse events from exercise. For the purpose of patients' safety, as well as because this study involves remote, home-based exercise where close supervision is not possible, patients with unstable medical conditions are excluded.
Subjects who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.

Study is for people with:

Colon Cancer

Estimated Enrollment:

84

Study ID:

NCT06202183

Recruitment Status:

Not yet recruiting

Sponsor:

Dana-Farber Cancer Institute

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There is 1 Location for this study

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Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Christina Dieli-Conwright, MPH, PhD
Contact
617-582-8321
[email protected]
Christina Dieli-Conwright, MPH, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Estimated Enrollment:

84

Study ID:

NCT06202183

Recruitment Status:

Not yet recruiting

Sponsor:


Dana-Farber Cancer Institute

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