Actively Recruiting
COMMENCER: COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER
Led by Massachusetts General Hospital · Updated on 2026-05-05
80
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of daily use of freeze-dried instant coffee on liver fat, liver fibrosis, and the gut microbiome in patients who have completed standard treatments for stage I-III colorectal cancer. This clinical trial aims to understand how coffee influences these factors and whether it may have a role in chemoprevention for colorectal cancer survivors. The study is designed to test the safety and effectiveness of this investigational intervention. Participants are randomly assigned to one of two groups: one group receives capsules containing Nestlé NESCAFÉ TASTER'S CHOICE House Blend coffee, equivalent to three cups daily, while the other group receives placebo capsules with similar appearance and flavor but without coffee. The treatment period lasts between 8 and 12 weeks. The coffee or placebo capsules are mailed to participants, who take 15 capsules daily during the study. During the study, participants attend two visits for assessments including proton magnetic resonance spectroscopy, magnetic resonance imaging, and ultrasound elastography. Researchers collect urine, blood, and stool samples, along with diet and lifestyle questionnaires and archival tumor biopsy tissue. The main outcome measured is the change in liver fat fraction, assessed two years after study completion, along with liver fibrosis and liver enzyme levels. The total participation includes screening, treatment, and long-term follow-up to monitor these outcomes.
CONDITIONS
Brief Title
COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed stage I, II, or III colon or rectal adenocarcinoma with standard treatment completed at least 2 months ago
- Age 18 years or older
- Adult participants only due to differences in colorectal cancer biology in children
- Agreement to use effective contraception during the study for women of child-bearing potential and men
- Ability and willingness to follow study procedures and instructions
- Ability to understand and sign informed consent
You will not qualify if you...
- Receiving any other investigational agents
- Concurrent use of anti-cancer therapies including chemotherapy, targeted agents, biological agents, immunotherapy, or other investigational agents
- Regular consumption of more than 2 cups of coffee daily for at least 3 days a week in the past month
- Use of coffee supplements within the past month
- History of conditions worsened by coffee such as arrhythmias, insomnia, tremors, tics, anxiety disorders, bipolar disease, panic attacks, Tourette's syndrome, epilepsy, or overactive bladder
- History of adverse reactions or intolerance to coffee
- Inability or unwillingness to swallow capsules
- History of malabsorption, uncontrolled vomiting or diarrhea, or other diseases affecting oral medication absorption
- Uncontrolled intercurrent illness including active infection, symptomatic heart failure, unstable angina, or psychiatric/social conditions that increase risk or limit compliance
- Pregnant or breastfeeding women
- Presence of synchronous malignancy under active treatment
- Known positive test for HIV, hepatitis C, or acute or chronic hepatitis B infection
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 to 12 weeks
Participants take daily capsules of either coffee or placebo for chemoprevention of colorectal cancer.
2 study visits including imaging and sample collections
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
M
Mingyang Song, MD, ScD
A
Aparna R Parikh, MD, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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