EGCG for Colorectal Cancer

Overseen By Jay L Morris, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Investigational agents

Disqualifiers: Metastatic disease, Stage III cancer, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 3

Duration: 1 year

51 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if a green tea compound, EGCG, can help prevent cancer from returning in patients with early-stage colon or rectal cancer after surgery. Patients will take EGCG daily for several months, and their progress will be monitored through blood tests and a colonoscopy. EGCG, the major active component of green tea, has been studied for its anti-cancer and anti-inflammatory effects, particularly in colorectal cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot participate if you are receiving other investigational agents or have certain health conditions that might interfere with the study.

Is EGCG safe for humans?

EGCG, a compound found in green tea, has been studied for its effects on cancer cells and is generally considered safe in humans, as it undergoes extensive biotransformation in the body. However, high concentrations can lead to saturation in the intestines, and its effects on cancer cells suggest it can induce stress pathways, which may not be harmful in normal doses. ^{1 2 3 4 5}

How is the drug EGCG unique in treating colorectal cancer?

EGCG, a major component of green tea, is unique in treating colorectal cancer because it inhibits tumor growth by blocking the VEGF/VEGFR axis, which is crucial for tumor blood vessel formation, and enhances the effectiveness of radiation therapy by activating specific cellular pathways. ^{1 2 6 7 8}

What evidence supports the effectiveness of the treatment EGCG for colorectal cancer?

Research shows that EGCG, a major component of green tea, can slow down the growth of colorectal cancer cells and reduce their ability to spread. It also helps prevent the formation of new blood vessels that tumors need to grow, making it a promising option for treating colorectal cancer. ^{1 2 8 9 10}

Who Is on the Research Team?

Sukeshi Patel, MD

Principal Investigator

CTRC (Cancer Therapy and Research Center) at UTHSCSA

Are You a Good Fit for This Trial?

This trial is for adults over 18 with confirmed primary colon or rectal adenocarcinoma that can be surgically removed and have not had cancer treatment. They must have adequate organ function, no metastatic disease, not be on other trials, and agree to use contraception if necessary.

Inclusion Criteria

My recent blood tests meet the required levels for treatment.

My colon or rectal cancer is confirmed and treatable but I haven't received any cancer treatments yet.

I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea or EGCG

I can take pills by mouth and don't have serious stomach or intestine problems.

I am not pregnant and agree to use birth control during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Blood draw prior to surgery, followed by surgical resection, and surgical pathologic specimen will be archived

Immediate

1 visit (in-person)

Post-Surgery Evaluation

Patient will be seen in 4-12 weeks to determine if adjuvant chemotherapy is indicated

4-12 weeks

1 visit (in-person)

Treatment

Patients randomized to the EGCG arm will start EGCG within 4-12 weeks of surgery and take EGCG 450 mg PO twice a day for 1 year

1 year

Blood draws at 0, 3, 6, 9, 12, 15, 18 months

Follow-up

Colonoscopy will be done at 1 year from diagnosis, with normal colonic tissue biopsies and any resected polyps collected

1 year

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Epigallocatechin gallate (EGCG)

Trial Overview The study tests the effects of Epigallocatechin gallate (EGCG), a compound found in green tea, as a chemopreventive agent in patients with resectable colorectal cancer who are undergoing surgery but not receiving neoadjuvant chemotherapy.

How Is the Trial Designed?

Group I: epigallocatechin gallate (EGCG) Experimental Treatment 1 Intervention

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

Group II: Observation Only Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Published Research Related to This Trial

(-)-Epigallocatechin-3-gallate (EGCG), a compound found in green tea, effectively inhibits the growth of colorectal cancer cells and induces cell death, showing promise as a chemotherapy agent against liver metastases.

In a study involving human colorectal cancer cell lines and SCID mice, EGCG not only reduced liver metastasis without causing weight loss or liver damage but also suppressed blood vessel formation in tumors, indicating its potential safety and efficacy in treating this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(-)-Epigallocatechin-3-gallate suppresses liver metastasis of human colorectal cancer. Maruyama, T., Murata, S., Nakayama, K., et al.[2016]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Epigallocatechin-3-gallate inhibits proliferation and migration of human colon cancer SW620 cells in vitro. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Green Tea Extract to Prevent Colorectal Adenomas, Results of a Randomized, Placebo-Controlled Clinical Trial. [2022]

3. Ireland pubmed.ncbi.nlm.nih.gov

(-)-Epigallocatechin gallate inhibits growth and activation of the VEGF/VEGFR axis in human colorectal cancer cells. [2022]

4. Greece pubmed.ncbi.nlm.nih.gov

(-)-Epigallocatechin-3-gallate suppresses liver metastasis of human colorectal cancer. [2016]

5. China pubmed.ncbi.nlm.nih.gov

[Effects of different catechins on cell cycle arrest and induction of apoptosis in LoVo cells]. [2013]

6. China pubmed.ncbi.nlm.nih.gov

[Protective effect of epigallocatechin-3-gallate on inflammatory bowel disease: experiment with rat models of induced colitis]. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Dose-dependent levels of epigallocatechin-3-gallate in human colon cancer cells and mouse plasma and tissues. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Induction of Endoplasmic Reticulum Stress Pathway by Green Tea Epigallocatechin-3-Gallate (EGCG) in Colorectal Cancer Cells: Activation of PERK/p-eIF2&#945;/ATF4 and IRE1&#945;. [2021]

9. Greece pubmed.ncbi.nlm.nih.gov

Epigallocatechin-3-gallate Enhances Radiation Sensitivity in Colorectal Cancer Cells Through Nrf2 Activation and Autophagy. [2021]

10. Japan pubmed.ncbi.nlm.nih.gov

Comparative examination of anti-proliferative activities of (-)-epigallocatechin gallate and (--)-epigallocatechin against HCT116 colorectal carcinoma cells. [2019]