Effects of coffee on gut microbiome and liver health in colorectal cancer patients
COMMENCER: COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER
This study is testing whether drinking 6 grams of freeze-dried instant coffee daily can improve liver health and gut bacteria in people who have finished treatment for colorectal cancer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05692024 on ClinicalTrials.gov |
What this trial studies
This research assesses the impact of daily consumption of 6 grams of freeze-dried instant coffee on liver fat, fibrosis, and the gut microbiome in patients who have completed treatment for stage I-III colorectal cancer. The study is designed as a chemoprevention trial, aiming to evaluate the safety and effectiveness of coffee as a potential intervention. Participants will undergo various assessments, including imaging and sample collections, over an 8-12 week period, with a total of 80 participants expected to be recruited.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed stage I, II, or III colorectal adenocarcinoma who have completed standard treatment at least 2 months prior.
Not a fit: Patients currently undergoing treatment for colorectal cancer or those with other types of cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into a novel dietary intervention that may improve health outcomes for colorectal cancer survivors.
How similar studies have performed: While observational studies have suggested potential benefits of coffee in colorectal cancer survival, this specific intervention approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. * History of malabsorption or uncontrolled vomiting or diarrhea, or any other disease that could interfere with absorption of oral medications. * Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that, in the opinion of the investigator, may increase the risks associated with study participation or study treatment, limit compliance with study requirements, or interfere with the interpretation of study results. * Pregnant or breastfeeding. The effects of coffee on the developing human fetus are unknown. For this reason, women of child-bearing potential 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 she is participating in this study, she should inform her treating physician immediately. Similarly, lactating women are excluded from this study because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with coffee. Consequently, breastfeeding should be discontinued if the mother is enrolled on the study. * Presence of synchronous (at the same time) malignancy for which the patient is currently receiving active treatment. * Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.
Where this trial is running
Boston, Massachusetts
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Aparna R Parikh, MD, MS — Massachusetts General Hospital
- Study coordinator: Mingyang Song, MD, ScD
- Email: msong2@mgh.harvard.edu
- Phone: (617) 643-3364
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.