Coffee for Colorectal Cancer

(COMMENCER Trial)

Overseen By Aparna R Parikh, MD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Massachusetts General Hospital

Must not be taking: Chemotherapy, Immunotherapy, others

Disqualifiers: Pregnancy, HIV, Hepatitis, others

Compensation: Varies

Number of Visits: 3

Duration: 8-12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the impact of a daily dose of freeze-dried instant coffee on liver health and gut bacteria in individuals who have completed standard treatments for stage I-III colorectal cancer. Participants will take either Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend coffee capsules or placebo capsules without active ingredients to compare effects. The trial suits those who finished treatment for stage I-III colorectal cancer at least two months ago and do not regularly drink more than two cups of coffee per day. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to contribute to early-stage research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using other anti-cancer therapies or investigational agents. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that drinking coffee is generally safe. Some studies even suggest that coffee might help protect against certain cancers, such as colorectal cancer. In this trial, participants will consume the equivalent of about three cups of coffee each day, using Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsules.

Coffee is a popular drink worldwide, and regular consumption hasn't been linked to any serious side effects. Most people handle coffee well, but some might experience mild effects like nervousness or an upset stomach, especially if they are not accustomed to it.

The trial is in its early stages, so researchers are still collecting detailed safety information. However, since coffee is commonly used in daily life, there is some confidence in its safety for this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for colorectal cancer, which often involve chemotherapy, radiation, or surgery, the investigational treatment uses a familiar and accessible active ingredient—Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend coffee. This treatment is unique because it leverages the potential health benefits of coffee in a concentrated capsule form, providing a daily dose equivalent to three cups of coffee. Researchers are excited about this approach as coffee contains compounds that might have anticancer properties, offering a novel and less invasive option for patients. Plus, the use of a coffee-based treatment could potentially reduce the side effects commonly associated with traditional cancer therapies.

What evidence suggests that this treatment might be an effective treatment for colorectal cancer?

Research has shown that drinking coffee might help protect against cancer. Some studies have found that people who drink more coffee have a lower chance of developing colon and rectal cancers. Observational data also suggests that coffee drinkers with colorectal cancer might live longer. Specifically, coffee drinkers had a 26% lower chance of developing colorectal cancer compared to non-drinkers. This trial will compare the effects of coffee with a placebo. Participants in the coffee arm will receive capsules containing Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend. These benefits likely stem from coffee's effects on bile production and its ability to influence the gut microbiome, the community of tiny organisms in the digestive system. ^{1 2 3 6 7}

Who Is on the Research Team?

Aparna Parikh, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

I had colon or rectal cancer, finished my treatment over 2 months ago, and it was stage I, II, or III.

I agree to use birth control during the study.

Exclusion Criteria

History of adverse reactions to coffee or intolerance of coffee consumption

Current or recent use of any coffee supplements

History of diagnosed conditions that may be worsened by coffee

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive coffee or placebo capsules daily for 8-12 weeks

8-12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Coffee Active Control 1 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

In a case-control study involving 50 cancer cases of the mouth and pharynx, 209 of the esophagus, and other digestive cancers with 1944 control subjects, no significant link was found between coffee consumption and cancers of the mouth, esophagus, stomach, liver, or pancreas.

The study indicated a potential protective effect of coffee against colon and rectal cancers, with lower relative risks associated with higher coffee consumption, suggesting that coffee may influence bile secretion and reduce harmful bile acids in the bowel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coffee consumption and digestive tract cancers. La Vecchia, C., Ferraroni, M., Negri, E., et al.[2007]

In a study of 1171 patients with advanced or metastatic colorectal cancer, increased coffee consumption was linked to a lower risk of cancer progression and death, suggesting potential benefits of coffee in this patient population.

Patients who consumed 2 to 3 cups of coffee daily had a 18% reduced risk of death and disease progression, while those drinking at least 4 cups daily had an even greater reduction in risk, indicating that both caffeinated and decaffeinated coffee may contribute to these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Coffee Intake With Survival in Patients With Advanced or Metastatic Colorectal Cancer. Mackintosh, C., Yuan, C., Ou, FS., et al.[2023]

A review of studies from 1990 to 2003 found that coffee consumption is associated with a reduced risk of colon cancer, with a pooled relative risk of 0.76, indicating a significant inverse relationship across various studies.

No significant association was found between decaffeinated coffee or tea and the risk of colon or rectal cancer, suggesting that the protective effects may be specific to caffeinated coffee.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coffee, decaffeinated coffee, tea and cancer of the colon and rectum: a review of epidemiological studies, 1990-2003. Tavani, A., La Vecchia, C.[2013]

A meta-analysis of 24 studies involving 14,846 colorectal cancer cases found that coffee drinkers have a lower risk of developing colorectal cancer, with an odds ratio of 0.83 compared to non/occasional drinkers.

The analysis suggests that higher coffee consumption is associated with a significant reduction in colorectal cancer risk, particularly for the highest drinkers, but also raises the possibility of reverse causation where individuals may reduce coffee intake after experiencing bowel symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coffee consumption and risk of colorectal cancer: a meta-analysis of case-control studies. Galeone, C., Turati, F., La Vecchia, C., et al.[2010]

In a large cohort study of 61,463 Swedish women followed for an average of 9.6 years, no significant association was found between coffee consumption and the risk of colorectal cancer, including both colon and rectal cancers.

The study suggests that previous claims about coffee having a protective effect against colorectal cancer may be premature, indicating that moderate to high coffee consumption is unlikely to influence cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coffee consumption and risk of colorectal cancer in a population based prospective cohort of Swedish women. Terry, P., Bergkvist, L., Holmberg, L., et al.[2019]

In a large prospective cohort study involving 47,605 participants in Japan, coffee consumption was found to have no significant association with the incidence of colorectal cancer over an 11.6-year follow-up period.

The study reported hazard ratios indicating that even high coffee consumption (3 or more cups per day) did not correlate with a reduced risk of colorectal cancer, suggesting that coffee does not influence cancer risk in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coffee consumption and the risk of colorectal cancer: a prospective cohort study in Japan. Naganuma, T., Kuriyama, S., Akhter, M., et al.[2016]

A large analysis of 2289 colorectal cancer cases and 3995 controls found no significant association between coffee consumption and the risk of developing colorectal cancer, with an odds ratio of 0.99 for total coffee drinkers compared to non-drinkers.

Even high consumption levels, such as five or more cups per day, and long-term consumption (50 years or more) did not show an increased risk, indicating that both regular and decaffeinated coffee do not appear to influence colorectal cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coffee consumption and colorectal cancer risk: a multicentre case-control study from Italy and Spain. Rosato, V., Guercio, V., Bosetti, C., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05692024

COffee and Metabolites Modulating the Gut MicrobiomE in ... 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 ...

2. withpower.com withpower.com/trial/phase-2-colorectal-neoplasms-5-2023-191d0

Coffee for Colorectal Cancer (COMMENCER Trial) Some studies have found that higher coffee consumption is linked to a lower risk of colon and rectal cancers, possibly due to coffee's effects on bile secretion ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-09606

Coffee Intake and Changes in the Gut Microbiome ... Increasing data suggest the anti-cancer benefit of coffee. Observational data have linked coffee drinking to better survival among patients with colorectal ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10271502/

Coffee consumption and risk of colorectal cancer: a meta- ... Results from case–control studies suggest coffee consumption can significantly decrease the risks of colorectal cancer and colon cancer, especially in Europe ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4874555/

Coffee Consumption and the Risk of Colorectal Cancer Coffee consumption was associated with 26% lower odds of developing CRC [Odds Ratio (drinkers versus non-drinkers)=0.74; 95% CI: 0.64–0.86; P<0.001]. The ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5386640/

Association of coffee consumption with risk of colorectal cancer In conclusion, coffee consumption is significantly associated with a decreased risk of colorectal cancer at ≥ 5 cups per day of coffee consumption. The findings ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23546611/

Coffee consumption and risk of colorectal cancer: a dose ... The results suggested that a significant association was found between coffee consumption and decreased risk of colorectal and colon cancer.