RecruitingPhase 1 / Phase 2

COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER

COMMENCER: COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how 6 grams of freeze-dried instant coffee each day affects liver fat, liver scarring, gut microbes, and chemicals made in the body. It is for adults who finished standard treatment for stage I, II, or III colon or rectal cancer at least 2 months ago.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have stage I, II, or III colon or rectal adenocarcinoma, a type of cancer confirmed by a tissue test.
  • Have finished standard cancer treatment, including surgery, chemotherapy, and radiation, at least 2 months ago.
  • Men and women who could become pregnant must agree to use birth control or avoid sex before joining and throughout the study.
  • Be able and willing to follow study instructions.
  • Be able to understand and sign a form agreeing to join the study.

Who can't join

  • Are receiving experimental drugs or other cancer treatment, including treatment for another cancer present at the same time.
  • In the past month, drank more than two 8-ounce cups of coffee a day on at least 3 days a week, or used coffee supplements.
  • Have had a bad reaction to coffee or cannot tolerate it.
  • Have a condition coffee could worsen: irregular heartbeat, trouble sleeping, shaking, tics, anxiety disorder, bipolar disorder, panic attacks, Tourette's, epilepsy (seizures), or an overactive bladder.
  • Cannot or will not swallow capsules, or have trouble absorbing medicines because of a disease, uncontrolled vomiting, or diarrhea.
  • Have an uncontrolled illness, such as an infection or heart problem, or mental health or life issues that could make the study unsafe or affect study participation or results.
  • Are pregnant or breastfeeding.
  • Have a known positive test for HIV, hepatitis C, or a current short-term or long-term hepatitis B infection.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. * 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.

Study sites (1)

MA