Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

All Conditions

Infections

Symptoms and General Pathology

Rare Diseases

Nasopharyngeal Carcinoma

Carcinoma

Epstein-Barr Virus Infections

Virus Diseases

Communicable Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Antineoplastic Agents

Neuroprotective Agents

All Drugs and Chemicals

Flavonoid

Epigallocatechin gallate

Antioxidants

Protective Agents

Epigallocatechin

EGCG 600 mg per day will be provided to the test group.Four capsules will be taken daily (2# bid) by the test individuals.

Epigallocatechin Gallate (EGCG)

Placebo

Tsang Wu Liu, MD

Jin Ch Lin, MD PHD

Jen Ya Chen, PHD

The purpose of this study is to investigate the EBV reactivation rate in post-radiation and remission NPC patients, evaluate the safety and tolerance of EGCG and analyze the observational correlation between EBV reactivation and clinical outcome.

Patients with pathologically proven NPC, stage II-IVB and finishing curative RT ≧70 Gy within 6 months (± induction/concurrent/adjuvant chemotherapy) will be candidates for this study. Before entry, 8 CC venous blood will be obtained for EBV DNA and antibody screen tests after patient's consent. Those who have undetectable plasma EBV DNA (0 copy/ml) and fulfilled with all inclusion and exclusion criteria will be registered.

Routine re-staging work-ups after RT should show no active lesion in nasopharynx, neck and distant organs. Re-staging survey should include nasopharyngoscope, pEBV DNA assay, CBC, platelet count, renal and liver function tests, CXR, abdominal sonography or CT scan, whole body bone scan, MRI or CT scan of the head and neck region.

Within one week after finishing registration, EGCG or placebo should be started. A blood sample before taking EGCG/placebo will be collected for antibodies test and pEBV DNA assay.

Epstein-Barr Virus Reactivation and the Effect of EGCG on Virus Reactivation in Remission Patients

Study of Epstein-Barr Virus Reactivation and the Effect of Dietary Supplement Epigallocatechin Gallate (EGCG) on Virus Reactivation in Remission Patients With Nasopharyngeal Carcinoma - A Randomized Trial

Reactivation of EBV is defined as

1.Antibody against EBV VCA: The IgA antibody titers will be detected by a commercial EBV VCA ELISA kit (RE 562 71, Immuno-Biological Laboratories, Germany) Patient's serum with anti-EBV VCA greater than 10U/ml will be considered as reactivation of EBV.

Observational analysis of the correlation between EBV reactivation and clinical outcome

Mackay Memorial Hospital

Taichung Veterans General Hospital

National Cheng-Kung University Hospital

Chang Gung Memorial Hospital

China Medical University Hospital

National Taiwan University Hospital

National Health Research Institutes, Taiwan

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Anticoagulants

Reproductive Control Agents

Other Dietary Supplements

Herbal and Botanical

Letrozole

Citric Acid

Sodium Citrate

Clomiphene

Enclomiphene

Zuclomiphene

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Citrate

EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.

EGCG 800mg daily with letrozole 5mg for 5 days.

800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months

Epigallocatechin gallate (EGCG)

Clomiphene Citrate

Esther Eisenberg, MD

Ayman Al-Hendy, MD,PhD

Heping Zhang, PhD

James Segars, MD

Hugh Taylor, MD

Frank Gonzales, MD

A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.

This will be a randomized, multi-center, pharmacokinetics and hepatic safety trial of EGCG with 36 total patients in 3 treatment arms. 36 women will be randomized to one of the following groups: EGCG daily alone, EGCG daily with clomiphene citrate and EGCG daily with letrozole. The randomization scheme will be stratified for age groups 18-29 and 30-40 and presence of uterine fibroids. The pharmacokinetics and hepatic safety of EGCG with clomiphene citrate and letrozole are unknown. The trial conducted in women with and without fibroids will allow comparisons between these groups. The results of this study will be used to confirm hepatic safety for the larger multi-center FRIEND study.

The 36 women will be randomized to one of the following groups:

1. EGCG daily alone.
2. EGCG daily with clomiphene citrate 100mg for 5 days.
3. EGCG daily with letrozole 5mg for 5 days.

Pharmacokinetics and Hepatic Safety of EGCG

Changes in epigallocatechin gallate (EGCG) from Visit 1 to Visit 4 (end of study). EGCG levels measured at 1 hour after taking study medication were used for both visits.

Changes in epigallocatechin (EGC) from Visit 1 to Visit 4 (end of study). EGC levels measured at 1 hour after taking study medication were used for both visits.

Changes in epicatechin gallate(ECG) from Visit 1 to Visit 4 (end of study). ECG levels measured at 1 hour after taking study medication were used for both visits.

Changes in total bilirubin between the 3 groups.

Changes in alanine aminotransferase /SGPT between the 3 groups.

Changes in Alkaline Phosphatase between the 3 groups.

Changes in Estrogen (E2) between the 3 groups.

Changes in endometrial thickness between the 3 groups.

Change in serum folate levels between MTHFR677-Wild Type (WT) group and MTHFR677-Hetero group

Change in serum folate levels between MTHFR1298-Wild Type (WT) group and MTHFR1298-Hetero group

Change in serum folate levels between DHFR-Wild Type (WT) group and DHFR-Hetero or homo group.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

University of Illinois at Chicago

Johns Hopkins University

University of Chicago

Yale University

Chair of Obstetrics, Gynecology and Reproductive Sciences

EGCG daily alone. 800mg

Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months

EGCG Daily Alone.

EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.

Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months

Clomiphene Citrate: 100 mg for 5 days

EGCG With Clomiphene Citrate

EGCG 800mg daily with letrozole 5mg for 5 days.

Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months

Letrozole: 5 mg for 5 days

EGCG With Letrozole

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dr. Heping Zhang

Changes in Epigallocatechin Gallate (EGCG)

Changes in Epigallocatechin (EGC)

Changes in Epicatechin Gallate(ECG)

Changes in Total Bilirubin

Changes in ALT/SGPT

Changes in Alkaline Phosphatase

Changes in Estrogen (E2)

Changes in Endometrial Thickness

MTHFR677-Wild Type (WT) Group

MTHFR677-Hetero Group

Change in Serum Folate Level Between MTHFR677-Wild Type (WT) Group and MTHFR677-Hetero Group

MTHFR1298-Wild Type (WT) Group

MTHFR1298-Hetero Group

Change in Serum Folate Level Between MTHFR1298-Wild Type (WT) Group and MTHFR1298-Hetero Group

DHFR-Wild Type (WT) Group

DHFR-Hetero or Homo Group.

Change in Serum Folate Level Between DHFR-Wild Type (WT) Group and DHFR-Hetero or Homo Group.

Overall Study

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Cirrhosis

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Fibrosis

Catechin

Epicatechin

Epigallocatechin gallate (EGCG) 600mg will be administered daily via oral route for the initial 12 consecutive weeks on an outpatient basis. The dose of 600 mg will be continued for the second 12 weeks if an interim HCC biomarker test at the end of week 8 improves. If the interim test does not improve without dose-limiting adverse events, the dose will be increased to 800mg for the second 12 weeks, All participants will receive 24 weeks of treatment in total.

Oral administration of placebo for 24 weeks

Placebo in the same capsule with the experimental agent (EGCG).

Yujin Hoshida, MD, PhD

This phase II trial tests epigallocatechin gallate (EGCG) for its efficacy and safety in preventing development of hepatocellular carcinoma (HCC) in patients with liver cirrhosis.

This study will evaluate whether EGCG favorably modulate an HCC risk biomarker (PLSec) with acceptable safety profile in patients with compensated cirrhosis and elevated HCC risk determined by clinical variable-based score (FIB-4 index) and PLSec. Sixty participants will be randomized (1:1) to either the study drub or placebo arm and receive the treatment for 24 weeks. The participants will orally take EGCG 600 mg capsules or placebo for the first 12 weeks. If an interim PLSec analysis at the end of week 8 is not improved without any dose-limiting adverse events, the dose will be increased to 800 mg for the second 12 weeks. If the interim PLSec is improved, 600 mg will be continued. After completing the 24-week treatment, change in the PLSec test with the treatment is calculated by comparing pre- and post-treatment serum samples in each patient, and the changes will be compared between the treatment arms (primary endpoint). Complete adverse event profiles will be recorded, and change in quality of life will be compared between the treatment arms (secondary endpoints). If optional paired liver biopsy tissues are obtained, changes in tissue-based HCC risk biomarker (PLS) and immunohistochemical markers of cell proliferation, neoplasm, senescence, and fibrogenesis will be determined, changes in the FIB-4 index and liver stiffness measurement will be determined, and association with incident HCC during the study period will be evaluated (exploratory endpoints).

EGCG for Hepatocellular Carcinoma Chemoprevention

Phase II Randomized Controlled Trial of Epigallocatechin Gallate for Hepatocellular Carcinoma Chemoprevention

When optional liver biopsy tissue is obtained, modulation of hepatic gene expression-based signature associated with HCC risk, Prognostic Liver Signature (PLS) is measured by comparing pre- and post-treatment liver biopsy samples. Change in HCC risk level will be quantified as combined enrichment score (CES) by comparing between the 2 time points. A positive and negative CES values indicate worsening and improvement of the PLS, respectively. Absolute value of the CES indicate magnitude of reduction (i.e., negative value) or increase (i.e., positive value) of HCC risk level. There is no defined range of CES. CES values are compared between the EGCG and placebo arms using two-sample t-test.

When optional liver biopsy tissue is obtained, change of immunohistochemical markers of cellular proliferation (Ki67), hepatic neoplasia (GST-p), cellular senescence (beta-gal), fibrogenesis (alpha-SMA) will be assessed using formalin-fixed pre-treatment paraffin-embedded (FFPE) tissues. Positivity for all of the markers will be quantified by higher intensity at pixel levels in captured images using the ImageJ software. The measurements are compared between the EGCG and placebo arms using one-sample t-test.

The participants will be regularly followed every 6 months for HCC development for their life time. HCC diagnosis is based on the American Association for Study of Liver Disease (AASLD) clinical practice guidelines. Time to HCC development will be calculated as days between the treatment initiation data and date of HCC diagnosis. Cumulative HCC incidence will be compared between the treatment arms using log-rank test and Cox regression within and beyond the study period. This exploratory analysis will be performed through study completion with an anticipated average time frame of 1 year.

HCC risk level at baseline and post-treatment will be determined as Prognostic Liver Secretome signature (PLSec) score, ranging from 0 (lowest risk) to 8 (highest risk).

Change in the biomarker-based HCC risk level will be calculated as delta-PLSec by subtracting the post-treatment PLSec score from the baseline pre-treatment PLSec score. delta-PLSec values will be compared between the EGCG and placebo arms using two-sample t-test.

Adverse events are monitored at least monthly and graded/recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5. The number and severity of adverse events will be tabulated and summarized across all grades. Grade 3+ adverse events will be similarly described and summarized separately.

Quality of life (QOL) will be measured by using the chronic liver disease questionnaire (CLDQ), which consists of 29 questions. Participants can select one answer from seven choices of descriptive answers for each question. Frequency distributions, graphical techniques and other descriptive measures will be used to summarize the results. When frequencies are compared, Fisher's exact test will be used.

University of Texas Southwestern Medical Center

Professor

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Central Nervous System Stimulants

Caffeine

Cola

Patients randomized to the EGCG arm, will start EGCG within 4-12 weeks of surgery and take EGCG 450 mg PO twice a day.

Standard of care surgical resection followed by standard of care colonoscopy at year.

Teavigo™ is a natural, caffeine-free, highly purified and refined green tea extract providing 94% epigallocatechin gallate (EGCG).\*

Epp Goodwin

Jay L Morris, PhD

Sukeshi P Arora, MD

Sukeshi Patel, MD

This will be a randomized, controlled pilot trial of patients with histological documentation of primary colon or rectal adenocarcinoma with resectable cancer, who have not received any treatments for cancer. If patient is a candidate for surgical resection, with no planned neoadjuvant chemotherapy, then the patient is eligible. All eligible subjects will be consented prior to surgery.

Part 1: Blood draw prior to surgery, followed by surgical resection, and surgical pathologic specimen will be archived. After surgery, patient will be seen in 4-12 weeks to determine if adjuvant chemotherapy is indicated, in which case patient will receive adjuvant therapy. At this visit a blood draw will be done.

Part 2: If the patient is stage 0/1/2 and no plan for adjuvant treatments, then the patient will be randomized in a 2:1 manner to EGCG 900 mg daily vs observation (standard of care) for 1 year. Patients randomized to the EGCG arm, will start EGCG within 4-12 weeks of surgery and take EGCG 450 mg PO twice a day. Blood draw will be done at 0, 3, 6, 9, 12, 15, 18 months. Colonoscopy will be done at 1 year from diagnosis, at which time normal colonic tissue biopsies as well as any resected polyps will be collected.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Epstein-Barr Virus Reactivation and the Effect of EGCG on Virus Reactivation in Remission Patients	NCT01744587	NPC	Epigallocatechi... Placebo	20 Years -	National Health Research Institutes, Taiwan
Pharmacokinetics and Hepatic Safety of EGCG	NCT04177693	Uterine Fibroid...	Epigallocatechi... Clomiphene Citr... Letrozole	18 Years - 40 Years	Yale University
EGCG for Hepatocellular Carcinoma Chemoprevention	NCT06015022	Cirrhosis, Live...	Epigallocatechi... Placebo	18 Years -	University of Texas Southwestern Medical Center
Chemopreventive Effects of Epigallocatechin Gallate (EGCG) in Colorectal Cancer (CRC) Patients	NCT02891538	Colon Cancer	Epigallocatechi...	18 Years -	The University of Texas Health Science Center at San Antonio

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