COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER — COMMENCER  

Colorectal Cancer Clinical Trial

Official title: COMMENCER: COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Coffee
• Colorectal Cancer
• Colorectal Neoplasms
• Fibrosis, Liver
• Gastrointestinal Microbiome
• Liver Cirrhosis
• Stenosis

• NCT number: NCT05692024
• Study type: Interventional
• Source: Massachusetts General Hospital
• Contact: Mingyang Song, MD, ScD
• Phone: (617) 643-3364
• Email: msong2@mgh.harvard.edu
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 21, 2024
• Completion date: December 1, 2027