Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06202183
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2024-01-02
Brief Title:
Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy The COURAGE Trial
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Exercise for Gut Microbiome in Patients With Young-Onset Colorectal Cancer Undergoing Chemotherapy The COURAGE Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
The names of the study groups involved in this study are
Exercise
Waitlist Control
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None