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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06202183
• Other study ID #: 23-341
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: July 31, 2027

Study information

• Verified date: January 2024
• Source: Dana-Farber Cancer Institute
• Contact: Christina Dieli-Conwright, MPH, PhD
• Phone: 617-582-8321
• Email: ChristinaM_Dieli-Conwright[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: July 31, 2027
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Metastatic Colon Cancer
• Metastatic Colorectal Cancer

Intervention

Behavioral:
• Exercise Program
A 12 week, home-based, virtually supervised, aerobic and resistance exercise training program comprised of 36 sessions. Participants will be provided with a home stationary bike, resistance bands, and Fitbit. Virtually supervised sessions will be accessible via Zoom platform. For participants who do not have a device, a Wi-Fi-enabled tablet will also be provided.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	American Cancer Society, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut Microbiome Genomes	Gut Microbiome Sequencing will be conducted using the stool samples at Baseline and Post-Intervention. Gut Microbiome sequencing will be performed using DNA and RNA extraction, which will analyze microbial genomes.	Baseline (Week 1) and Post-intervention (Week 13)
Secondary	Change in Chemotherapy Toxicity	To evaluate changes in chemotherapy toxicity following a exercise intervention in survivors of young-onset CRC undergoing chemotherapy.	12 weeks