COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER

Description

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

Colorectal Cancer, Coffee, Gastrointestinal Microbiome, Stenosis, Fibrosis, Liver, Ultrasound Elastography, Proton Magnetic Resonance Spectroscopy

Study Overview

Study Details

Study overview

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.

COMMENCER: COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER

COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER

Condition
Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Aparna R Parikh, MD, MS, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2027-12-01