COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER

NCT ID: NCT05692024

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-21
• Study Completion Date: 2027-12-01

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Coffee

Participants in the active arm will take 15 capsules of coffee, each of which will contain 400 mg Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend (equivalent daily dose: three cups of coffee). Participants will receive a twelve-week supply of blinded drug capsules in the mail from Johnson Compounding Pharmacy. The anticipated duration of the study is at least 8 weeks and no more than 12 weeks.

Group Type: ACTIVE_COMPARATOR

Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule.

Intervention Type: DRUG

Each coffee capsule will contain 400 mg Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend.

Placebo

Participants in the placebo arm will take 15 capsules of placebo. Each placebo capsule will contain 400 mg of microcrystalline cellulose with flavor and food-coloring substances. Participants will receive a twelve-week supply of blinded drug capsules in the mail from Johnson Compounding Pharmacy. The anticipated duration of the study is at least 8 weeks and no more than 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Each placebo capsule will contain 400 mg of microcrystalline cellulose with flavor and food-coloring substances.

Interventions

Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule.

Each coffee capsule will contain 400 mg Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend.

Intervention Type: DRUG

Placebo

Each placebo capsule will contain 400 mg of microcrystalline cellulose with flavor and food-coloring substances.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mingyang Song

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aparna R Parikh, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mingyang Song, MD, ScD

Role: CONTACT

msong2@mgh.harvard.edu

(617) 643-3364

Aparna R Parikh, MD, MS

Role: CONTACT

APARNA.PARIKH@MGH.HARVARD.EDU

(617) 726-4000

Facility Contacts

Mingyang Song, MD

Role: primary

msong2@mgh.harvard.edu

617-643-4464

Other Identifiers

R01CA263776

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-061

Identifier Type: -

Identifier Source: org_study_id