Colorectal CancerPhase 1/2COMMENCERNCT05692024
COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER
A Phase 1/2 study testing Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule. in people with Colorectal Cancer and Coffee, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Coffee, Gastrointestinal Microbiome
- What is being tested?
- Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2024to 31 Aug 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02115
Mingyang Song, MD, 617-643-4464, msong2@mgh.harvard.edu
Mingyang Song, MD
About this study
Official title: COMMENCER: COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER
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.
Read the 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
- Being tested
- Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule., Placebo
- Keywords
- Liver fat, Gut microbiome, Colorectal cancer, Coffee, Tumor biopsy
- Medical subject headings
- Colorectal Neoplasms, Constriction, Pathologic, Liver Cirrhosis, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule.Drug
Each coffee capsule will contain 400 mg Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend.
PlaceboDrug
Each placebo capsule will contain 400 mg of microcrystalline cellulose with flavor and food-coloring substances.
| Study group | Role | What they receive |
|---|---|---|
| Coffee | Active comparator | 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. Receives: Drug: Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule. |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hepatic fat fraction.
This will be assessed by proton magnetic resonance spectroscopy (1H-MRS) at randomization and the end of the intervention: The investigators will assess the treatment effect using linear mixed effects model that includes time, group assignment, and the group-by-time interaction as the primary independent variables.
Measured: 2 years after study completion
Secondary outcomes (1)
Change in liver fibrosis assessment and plasma levels of liver enzymes
This will be analyzed including the score assessed by the FibroScan® system, plasma liver enzymes, and fibrosis-4 index, at randomization and the end of the intervention: The investigators will assess the treatment effect using linear mixed effects model that includes time, group assignment, and the group-by-time interaction as the primary independent variables.
Measured: 2 years after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start21 Mar 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mingyang Song, Massachusetts General Hospital
- Investigators
- Aparna R Parikh, MD, MS, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692024
- Sponsor's protocol ID
- 23-061
- Other IDs
- R01CA263776
- Acronym
- COMMENCER
- Status last verified
- Apr 2026
- First submitted
- 8 Jan 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results should be made public within 24 months of reaching the end of the study upon review by the MGH Research Pharmacy staff and acknowledgement of the CTP. The end of the study is the time point at which the last data items are to be reported, or after the outcome data are sufficiently mature for analysis, as defined in the section on Sample Size, Accrual Rate and Study Duration. If a report is planned to be published in a peer-reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors. A full report of the outcomes should be made public no later than three (3) years after the end of the study.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMMENCER: COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER
- ClinicalTrials.gov ID
- NCT05692024
- Acronym / sponsor ID
- COMMENCER / 23-061
- Conditions
- Colorectal Cancer, Coffee, Gastrointestinal Microbiome, Stenosis, Fibrosis, Liver, Ultrasound Elastography
- Keywords
- Liver fat, Gut microbiome, Colorectal cancer, Coffee, Tumor biopsy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coffee | Active comparator | Drug: Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule.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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule.Each coffee capsule will contain 400 mg Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend. | Drug | Coffee |
| PlaceboEach placebo capsule will contain 400 mg of microcrystalline cellulose with flavor and food-coloring substances. | Drug | Placebo |
Primary outcome
Change in hepatic fat fraction.
Time frame: 2 years after study completion
This will be assessed by proton magnetic resonance spectroscopy (1H-MRS) at randomization and the end of the intervention: The investigators will assess the treatment effect using linear mixed effects model that includes time, group assignment, and the group-by-time interaction as the primary independent variables.
1 secondary outcome
Change in liver fibrosis assessment and plasma levels of liver enzymes
Time frame: 2 years after study completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: Yes. The results should be made public within 24 months of reaching the end of the study upon review by the MGH Research Pharmacy staff and acknowledgement of the CTP. The end of the study is the time point at which the last data items are to be reported, or after the outcome data are sufficiently mature for analysis, as defined in the section on Sample Size, Accrual Rate and Study Duration. If a report is planned to be published in a peer-reviewed journal, then that initial release may be an abstract that meets the requirements of the International Committee of Medical Journal Editors. A full report of the outcomes should be made public no later than three (3) years after the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aparna R Parikh, MD, MS principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule. in people with Colorectal Cancer and Coffee, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingyang Song, MD, ScD ((617) 643-3364, msong2@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hepatic fat fraction. (time frame: 2 years after study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.