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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06202183
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Exercise Program — BEHAVIORAL
    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.

Study Details

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

Key Dates

Start date
Jul 22, 2024
Status verified
Aug 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Group A: Exercise Group
    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.
  • No Intervention: Group B: Waitlist Control Group
    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.

Primary Outcome Measure

Gut Microbiome Genomes [ Time Frame: Baseline (Week 1) and Post-intervention (Week 13) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215
Christina Dieli-Conwright, MPH, PhD
[email protected]
617-582-8321
Christina Dieli-Conwright, MPH, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Dana Farber Cancer Institute· Boston, MA

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