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New treatment option for Colorectal Cancer
Official title COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER
ClinicalTrials.gov ID: NCT05692024
What this study is testing
What is Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule.?
Nestlé NESCAFÉ® TASTER'S CHOICE® House Blend capsule. is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- 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...
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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...
- people must be able and willing to follow study procedures and instructions.
- Ability to understand and the willingness to sign a written informed consent document.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.