Green Tea Extract for Liver Cirrhosis

Not currently recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Investigational agents

Disqualifiers: HCC, Other cancer, Decompensated liver, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a green tea extract (Defined Green Tea Catechin Extract) to determine the optimal dose and identify any side effects. The goal is to assess whether this extract can help prevent liver cancer in individuals with cirrhosis, a condition where the liver becomes scarred. The trial seeks participants diagnosed with cirrhosis who have high levels of a molecule linked to liver cancer risk. Participants must be willing to limit their green tea intake and avoid green tea supplements during the study. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that participants should not take supplements or foods labeled as containing green tea for 8 weeks before starting the treatment.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown mixed safety results for the green tea extract being tested for liver cirrhosis. Some studies indicate that liver problems from green tea extracts are rare. Out of 38 studies, 26 reported no liver issues. However, over 200 cases of serious liver injury have been linked to green tea. Safety data suggests a safe daily amount of 338 mg of the main ingredient, EGCG. While some risk exists, many studies have found no harmful effects on the liver. Participants should consider these findings and consult a healthcare professional before deciding to join the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for liver cirrhosis, which often include medications like diuretics and beta-blockers, the green tea catechin extract is derived from a natural source, offering a potentially safer alternative with fewer side effects. Researchers are excited about this treatment because it utilizes catechins, powerful antioxidants, which may protect liver cells and reduce liver damage. This approach targets the underlying oxidative stress in liver cirrhosis, offering a novel mechanism of action compared to traditional therapies.

What evidence suggests that defined green tea catechin extract might be an effective treatment for liver cirrhosis?

Research suggests that a specific green tea extract, which participants in this trial will receive, might help lower the risk of liver disease. A study that combined results from multiple research papers found that people who drink green tea have a 32% lower risk of liver disease. This extract may work by reducing a molecule linked to liver cancer risk in people with liver scarring. Although concerns exist about green tea causing liver problems, other studies have found no harmful effects on the liver, especially in people with healthy liver function. Early findings indicate that the extract might help prevent liver cancer by addressing certain risk factors. ^{2 3 4 6 7}

Who Is on the Research Team?

Aiwu R He

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

Adults diagnosed with cirrhosis who can undergo imaging tests like ultrasound, CT, or MRI. They must have a good performance status (able to carry out daily activities), adequate blood counts and liver function, no history of certain cancers within the last 3 years except some localized ones, not be pregnant or breastfeeding, and agree to use contraception. Excluded are those with bleeding risks, allergies to green tea components, recent consumption of green tea products, other active cancers requiring systemic treatment or hepatic decompensation events.

Inclusion Criteria

I can undergo scans for my condition.

I am fully active or can carry out light work.

I do not have fluid buildup in my abdomen or brain function issues.

Exclusion Criteria

I am mentally capable of understanding and consenting to treatment.

Recent consumption of green tea-containing supplements or foods

I cannot swallow pills.

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 defined green tea catechin extract orally once or twice daily for 24 weeks

24 weeks

Regular visits for imaging and blood sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Defined Green Tea Catechin Extract

Trial Overview The trial is testing defined green tea catechin extract's ability to prevent liver cancer in cirrhotic patients by lowering gamma-OHPdG levels. Participants will receive varying doses of this extract while being monitored through imaging studies and laboratory biomarker analysis for any changes in their condition.

How Is the Trial Designed?

Group I: Prevention (defined green tea catechin extract) Experimental Treatment 9 Interventions

Participants receive defined green tea catechin extract PO QD or BID for 24 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo ultrasound, CT, or MRI at screening and on study, undergo collection of blood samples on study, and may undergo biopsy at screening and on study.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The systematic review found that while green tea extracts (GTE) can contain potentially harmful substances, there was no direct evidence linking these contaminants to liver injury, although hepatotoxicity has been associated with high doses of EGCG (140 mg to 1000 mg/day).

Due to the risk of liver injury, the United States Pharmacopeia now recommends that GTE should not be taken on an empty stomach and advises against use in individuals with liver problems, highlighting the importance of taking GTE with food and monitoring for symptoms of liver issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

United States Pharmacopeia (USP) comprehensive review of the hepatotoxicity of green tea extracts. Oketch-Rabah, HA., Roe, AL., Rider, CV., et al.[2020]

In a 12-week study involving 17 patients with non-alcoholic fatty liver disease (NAFLD), consumption of green tea with high-density catechins significantly reduced body fat and improved liver health, as indicated by better liver-to-spleen CT attenuation ratios.

The high-density catechin group also showed significant decreases in serum alanine aminotransferase (ALT) levels and urinary 8-isoprostane excretion, suggesting that green tea may help reduce liver inflammation and oxidative stress in NAFLD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Green tea with high-density catechins improves liver function and fat infiltration in non-alcoholic fatty liver disease (NAFLD) patients: a double-blind placebo-controlled study. Sakata, R., Nakamura, T., Torimura, T., et al.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9745259/

Green tea extract–associated acute liver injury: Case report ... More than 200 cases of liver failure, sometimes even requiring liver transplantation, associated with green tea have been published within the last 30 years.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0273230018300928

The safety of green tea and green tea extract consumption ... No adverse effects on liver reported. Other Green Tea Extract Capsules ... EGCG identified herein are more appropriate for those with normal liver function.

3. withpower.com withpower.com/trial/phase-1-liver-cirrhosis-7-2018-59420

Green Tea Extract for Liver Cirrhosis · Info for Participants Trial Overview The trial is testing defined green tea catechin extract's ability to prevent liver cancer in cirrhotic patients by lowering gamma-OHPdG levels.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4538013/

The effect of green tea intake on risk of liver disease Results: Meta-analysis revealed that among green tea drinkers, there was a significant reduction in the risk of liver disease (RR=0.68, 95% CI=0.56-0.82, P= ...

5. cancer.gov cancer.gov/clinicaltrials/NCI-2017-01557

Defined Green Tea Catechin Extract in Preventing Liver ... Defined green tea catechin extract may work better to lower levels of gamma-OHPdG and prevent the development of liver cancer.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5193539/

Liver-related safety assessment of green tea extracts in ... Results of this review, although not conclusive, suggest that liver-related adverse events after intake of green tea extracts are expected to be rare.

7. efsa.onlinelibrary.wiley.com efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2018.5239

Scientific opinion on the safety of green tea catechins - - 2018 Of the 38 studies, 26 reported that there were no effects on liver parameters, of which 22 were studies with green tea extracts.