RecruitingColorectal CancerCoffeeGastrointestinal Microbiome
COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Massachusetts General Hospital
You may qualify if…
- ✓ Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- ✓ 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.
- ✓ This study will only include adult participants because colorectal carcinogenesis in children is more likely to be related to a cancer predisposition syndrome with distinct biological mechanisms compared with sporadic colorectal cancer in adults.
- ✓ The effects of coffee on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- ✓ Subjects must be able and willing to follow study procedures and instructions.
- ✓ Ability to understand and the willingness to sign a written informed consent document.
You may not qualify if…
- ✕ Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
- ✕ Participants who are receiving any other investigational agents.
- ✕ Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol.
- ✕ Regularly consuming more than 2 cups of coffee ( 8 oz) per day for at least 3 days a week in the past month.
- ✕ Current or recent use (within 1 month) of any coffee supplements (e.g., green coffee extracts).
- ✕ History of diagnosed conditions that may be worsen by coffee, including arrhythmias, insomnia, tremors, tics, generalized anxiety disorder, bipolar disease, panic attacks, Tourette's, epilepsy or overactive bladder.
- ✕ History of adverse reactions to coffee or intolerance of coffee consumption.
- ✕ Inability or unwillingness to swallow capsules.
Where it's recruiting
Massachusetts
Boston
Source: ClinicalTrials.gov · NCT05692024 · last updated 2026-05-05