Actively Recruiting
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
232 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
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.
CONDITIONS
Official Title
COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have histologically confirmed stage I, II, or III colon or rectal adenocarcinoma and have completed standard treatment (including surgery, chemotherapy and radiotherapy) at least 2 months ago.
- Age 18 years or older.
- Only adult participants included due to different biological mechanisms in pediatric colorectal cancer.
- Women of child-bearing potential and men must agree to use adequate contraception during study participation.
- Subjects must be able and willing to follow study procedures and instructions.
- Ability to understand and willingness to sign informed consent.
You will not qualify if you...
- Receiving any other investigational agents.
- Using other anti-cancer therapies concurrently, including chemotherapy, targeted agents, biological agents, immunotherapy, or investigational agents not specified.
- Regularly consuming more than 2 cups of coffee per day for at least 3 days a week in the past month.
- Current or recent use (within 1 month) of any coffee supplements.
- History of conditions worsened by coffee such as arrhythmias, insomnia, tremors, tics, anxiety disorders, bipolar disease, panic attacks, Tourette's, 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 interfering with oral medication absorption.
- Any uncontrolled illness including active infection, symptomatic heart failure, unstable angina, or psychiatric/social issues increasing risk or limiting compliance.
- Pregnant or breastfeeding women.
- Presence of synchronous malignancy under active treatment.
- Known positive test for HIV, hepatitis C, or acute/chronic hepatitis B infection.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
M
Mingyang Song, MD, ScD
CONTACT
A
Aparna R Parikh, MD, MS
CONTACT
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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