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COMMENCER: COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER
This is research study is assessing the effects of 6-g daily use of freeze-dried instant coffee on liver fat and fibrosis and the gut microbiome and metabolome in patients who have completed routine treatment (including surgery, chemotherapy and radiotherapy) for stage I-III colorectal cancer.
This research study is a chemoprevention clinical trial, designed to test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the drug is being studied. The investigators plan to recruit 80 participants. * Coffee is a complex mixture of hundreds of bioactive compounds, including caffeine, chlorogenic acids, and other polyphenols. Increasing data suggest the anti-cancer benefit of coffee. Observational data have linked coffee drinking to better survival among patients with colorectal cancer. However, there remains uncertainty surrounding the mode of action. * The U.S. Food and Drug Administration (FDA) has not approved coffee as a treatment for any disease. * The research study procedures include: * Screening for eligibility. * Two study visits * Proton magnetic resonance spectroscopy. * Magnetic resonance imaging * Ultrasound elastography. * Urine, blood, and stool samples collected. * Diet and lifestyle questionnaires * Collection of archival tumor biopsy tissue. * Treatment: Coffee or placebo administered daily, orally for 8-12 weeks.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Massachusetts General Hospital
Boston, Massachusetts, United States
Start Date
March 21, 2024
Primary Completion Date
December 31, 2026
Completion Date
December 1, 2027
Last Updated
May 8, 2025
80
ESTIMATED participants
Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule.
DRUG
Placebo
DRUG
Lead Sponsor
Massachusetts General Hospital
Collaborators
NCT04704661
NCT06696768
Data Source & Attribution
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