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Trial Title:
COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER
NCT ID:
NCT05692024
Condition:
Colorectal Cancer
Coffee
Gastrointestinal Microbiome
Stenosis
Fibrosis, Liver
Ultrasound Elastography
Proton Magnetic Resonance Spectroscopy
Conditions: Official terms:
Colorectal Neoplasms
Liver Cirrhosis
Conditions: Keywords:
Liver fat
Gut microbiome
Colorectal cancer
Coffee
Tumor biopsy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule.
Description:
Each coffee capsule will contain 400 mg Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend.
Arm group label:
Coffee
Intervention type:
Drug
Intervention name:
Placebo
Description:
Each placebo capsule will contain 400 mg of microcrystalline cellulose with flavor and
food-coloring substances.
Arm group label:
Placebo
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.
Detailed description:
This research study is a chemoprevention clinical trial, designed to test the safety and
effectiveness of an investigational intervention to learn whether the intervention works
in treating a specific disease. "Investigational" means that the drug is being studied.
The investigators plan to recruit 80 participants.
- Coffee is a complex mixture of hundreds of bioactive compounds, including caffeine,
chlorogenic acids, and other polyphenols. Increasing data suggest the anti-cancer
benefit of coffee. Observational data have linked coffee drinking to better survival
among patients with colorectal cancer. However, there remains uncertainty
surrounding the mode of action.
- The U.S. Food and Drug Administration (FDA) has not approved coffee as a treatment
for any disease.
- The research study procedures include:
- Screening for eligibility.
- Two study visits
- Proton magnetic resonance spectroscopy.
- Magnetic resonance imaging
- Ultrasound elastography.
- Urine, blood, and stool samples collected.
- Diet and lifestyle questionnaires
- Collection of archival tumor biopsy tissue.
- Treatment: Coffee or placebo administered daily, orally for 8-12 weeks.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mingyang Song, MD
Phone:
617-643-4464
Email:
msong2@mgh.harvard.edu
Investigator:
Last name:
Mingyang Song, MD
Email:
Principal Investigator
Start date:
March 21, 2024
Completion date:
December 1, 2027
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05692024