NCT05692024 COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER
| NCT ID | NCT05692024 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Massachusetts General Hospital |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-03-21 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2024-03-21 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Aparna R Parikh, MD, MS
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT05692024 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05692024 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05692024 currently recruiting?
Yes, NCT05692024 is actively recruiting participants. Contact the research team at msong2@mgh.harvard.edu for enrollment information.
Where is the NCT05692024 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05692024 clinical trial?
NCT05692024 is sponsored by Massachusetts General Hospital. The principal investigator is Aparna R Parikh, MD, MS at Massachusetts General Hospital. The trial plans to enroll 80 participants.
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