Chemopreventive Effects of Epigallocatechin Gallate (EGCG) in Colorectal Cancer (CRC) Patients

NCT02891538 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: CTMS 16-008516-446H
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colon Cancer

Keywords

EGCG; Green Tea; Colon Cancer

Outcome Measures

Primary Outcomes (1)

• Change in methylation from baseline when compared to the control arm

  1 year

Study Arms (2)

epigallocatechin gallate (EGCG)

EXPERIMENTAL

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

Drug: Epigallocatechin gallate (EGCG)

Observation Only

NO INTERVENTION

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

Interventions

Epigallocatechin gallate (EGCG) DRUG

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

Also known as: Green Tea Extract

epigallocatechin gallate (EGCG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cytologically or histologically confirmed of primary colon or rectal adenocarcinoma with resectable cancer, who have not received any treatments for cancer.
• Age 18 years and above
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• The patient is a candidate for surgical resection, with no planned neoadjuvant chemotherapy, and there is a planned surgery for the primary colorectal cancer cancer or the patient had recent resection of the primary colorectal cancer. .
• For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception. For men: agreement to use a barrier method of contraception during the treatment period
• Hematologic, Biochemical, and Organ Function within 7 days prior to Cycle 1 Day 1: Granulocyte count \> 1000/mm3, Platelet count \> 50,000/ mm3, Hemoglobin \> 7 g/dL; Total bilirubin \< 1.5xULN; Albumin \> 2.8g/dl; aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) \</=2.5 x upper limit of normal (ULN); Serum creatinine\< 2 x ULN

You may not qualify if:

• Patients receiving prior chemotherapy or chemoradiation for colorectal cancer (ie, neoadjuvant chemoradiation for stage II or III rectal cancer).
• Known diagnosis of stage III colon or rectal cancer will be excluded from the study.
• Patients with metastatic disease.
• Patients may not be receiving any other investigational agents.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea or EGCG.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease. Patients with nasogastric tube (NG-tube), J-tube, or G-tube will not be allowed to participate.
• Pregnant women are excluded from this study because of unknown effects of EGCG on teratogenic or abortifacient effects. For this reason, women of childbearing potential and men must also agree to use adequate contraception (hormonal or barrier method of birth control) 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. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with EGCG, breastfeeding should be discontinued.
• Informed Consent - No study specific procedures will be performed without a written and signed informed consent document. Patients who do not demonstrate the ability to understand or the willingness to sign the written informed consent document will be excluded from study entry.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

epigallocatechin gallate; Tea

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Sukeshi Patel, MD

  CTRC (Cancer Therapy and Research Center) at UTHSCSA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 7, 2016
• Study Start: January 31, 2017
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)