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Coffee for Colorectal Cancer (COMMENCER Trial)
Phase 1 & 2
Recruiting
Led By Mingyang Song, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years after study completion
Awards & highlights
COMMENCER Trial Summary
This trial studies the effects of coffee on liver fat, fibrosis, and gut microbiome in colon cancer patients.
Who is the study for?
Adults over 18 who've completed treatment for stage I-III colorectal cancer can join. They must be able to follow the study plan, sign consent, and use contraception if of childbearing potential. Excluded are heavy coffee drinkers, those with certain health conditions worsened by coffee or on other cancer treatments.Check my eligibility
What is being tested?
The trial is testing whether daily consumption of freeze-dried instant coffee affects liver fat, fibrosis, gut microbiome and metabolome in patients post-treatment for colorectal cancer. Participants will either receive the actual coffee product or a placebo.See study design
What are the potential side effects?
Potential side effects may include typical reactions to caffeine such as jitteriness, increased heart rate, trouble sleeping (insomnia), upset stomach or digestive discomfort.
COMMENCER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years after study completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years after study completion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in hepatic fat fraction.
Secondary outcome measures
Change in liver fibrosis assessment and plasma levels of liver enzymes
Other outcome measures
Change in stool metabolomics
Change in the stool microbiome
ctDNA analysis
COMMENCER Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: CoffeeActive Control1 Intervention
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 II: PlaceboPlacebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,934 Previous Clinical Trials
13,198,501 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,669 Previous Clinical Trials
40,926,321 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,770 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had colon or rectal cancer, finished my treatment over 2 months ago, and it was stage I, II, or III.I am not using any other cancer treatments.I do not have any uncontrolled illnesses.I am currently being treated for another cancer at the same time.I agree to use birth control during the study.I am 18 years old or older.I am willing and able to follow the study's procedures and instructions.I have a history of severe digestion problems.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Coffee
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacant slots remaining for participants in this trial?
"Unfortunately, according to clinicaltrials.gov this study is no longer open for recruitment and has not been updated since January 19th 2023. Despite this, there are still 1,243 different trials actively seeking participants at the moment."
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