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 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.

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 coffee safe for humans in clinical trials?

Research suggests that coffee consumption is generally safe for humans and may even have protective effects against certain types of cancer, including colorectal cancer. Studies have not found significant harmful associations between coffee and various digestive tract cancers. ^{1 2 3 4 5}

How does coffee as a treatment differ from other treatments for colorectal cancer?

Coffee is unique as a treatment for colorectal cancer because it contains compounds with antioxidant and anti-inflammatory properties that may help reduce cancer risk and improve survival. Unlike traditional cancer treatments, coffee is a natural beverage that may offer protective effects through regular consumption, potentially lowering the recurrence and mortality rates of colorectal cancer. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule for colorectal cancer?

Research suggests that coffee contains compounds with antioxidant and anti-inflammatory effects, which may help reduce the risk of colorectal cancer. 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 and its antimutagenic properties. ^{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

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

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

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 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]

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 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]

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 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]

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 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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Association of Coffee Intake With Survival in Patients With Advanced or Metastatic Colorectal Cancer. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Coffee consumption and digestive tract cancers. [2007]

3. England pubmed.ncbi.nlm.nih.gov

Coffee consumption and risk of colorectal cancer in a population based prospective cohort of Swedish women. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Coffee consumption and colorectal cancer risk: a multicentre case-control study from Italy and Spain. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Coffee consumption and risk of colorectal cancer: a meta-analysis of case-control studies. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Coffee consumption and the risk of colorectal cancer: a prospective cohort study in Japan. [2016]