RECRUITING

COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER

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Conditions

Colorectal CancerCoffeeGastrointestinal MicrobiomeStenosisFibrosis, LiverUltrasound ElastographyProton Magnetic Resonance SpectroscopyLiver fatGut microbiomeTumor biopsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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.

Official Title

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

Quick Facts

Study Start:2024-03-21
Study Completion:2027-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05692024

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Age 18 years or older.
  3. * 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.
  4. * 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.
  5. * Subjects must be able and willing to follow study procedures and instructions.
  6. * Ability to understand and the willingness to sign a written informed consent document.
  1. * Participants who are receiving any other investigational agents.
  2. * Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol.
  3. * Regularly consuming more than 2 cups of coffee ( 8 oz) per day for at least 3 days a week in the past month.
  4. * Current or recent use (within 1 month) of any coffee supplements (e.g., green coffee extracts).
  5. * 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.
  6. * History of adverse reactions to coffee or intolerance of coffee consumption.
  7. * Inability or unwillingness to swallow capsules.
  8. * History of malabsorption or uncontrolled vomiting or diarrhea, or any other disease that could interfere with absorption of oral medications.
  9. * 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.
  10. * 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.
  11. * Presence of synchronous (at the same time) malignancy for which the patient is currently receiving active treatment.
  12. * Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.

Contacts and Locations

Study Contact

Mingyang Song, MD, ScD
CONTACT
(617) 643-3364
msong2@mgh.harvard.edu
Aparna R Parikh, MD, MS
CONTACT
(617) 726-4000
APARNA.PARIKH@MGH.HARVARD.EDU

Principal Investigator

Aparna R Parikh, MD, MS
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-21
Study Completion Date2027-12-01

Study Record Updates

Study Start Date2024-03-21
Study Completion Date2027-12-01

Terms related to this study

Keywords Provided by Researchers

  • Liver fat
  • Gut microbiome
  • Colorectal cancer
  • Coffee
  • Tumor biopsy

Additional Relevant MeSH Terms

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