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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

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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years after study completion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in hepatic fat fraction.

Secondary study objectives

Change in liver fibrosis assessment and plasma levels of liver enzymes

Other study objectives

Change in stool metabolomics

Change in the stool microbiome

ctDNA analysis

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.

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