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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects of Epigallocatechin gallate (EGCG), a compound in green tea, on colorectal cancer. Researchers aim to determine if taking EGCG after surgery benefits individuals with colon or rectal cancer that hasn't spread or been treated. The study includes two groups: one will take EGCG, while the other will receive standard care without it. Individuals with primary colon or rectal cancer who have not yet undergone any cancer treatments and are planning surgery may be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how EGCG works in people, offering participants a chance to be among the first to receive this treatment.

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 there any evidence suggesting that Epigallocatechin gallate (EGCG) is likely to be safe for humans?

Research suggests that a compound called Epigallocatechin gallate (EGCG) might help protect against colon cancer. Studies have found that EGCG can stop cancer cells from growing and can even cause them to die by affecting certain processes in the cells that lead to cancer.

This trial is in an early stage, focusing primarily on the safety of EGCG for people. In other studies with animals, EGCG significantly reduced tumor growth without major safety issues. However, more research is needed to confirm its safety in humans.

For those considering joining a clinical trial with EGCG, this early phase is crucial for understanding how well people handle the treatment. While there is potential, researchers are still learning about possible side effects in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Epigallocatechin gallate (EGCG) is unique because it is a natural compound found in green tea that offers a new way to potentially fight colorectal cancer. Unlike traditional treatments like chemotherapy and surgery, which target cancer cells directly or remove them, EGCG is thought to work by inhibiting cancer cell growth and inducing cell death through its antioxidant properties. Researchers are excited about EGCG because it might offer a less invasive option with fewer side effects, providing patients with a more natural alternative to current standard treatments.

What evidence suggests that Epigallocatechin gallate (EGCG) might be an effective treatment for colorectal cancer?

Research has shown that a compound called epigallocatechin gallate (EGCG) may help treat colorectal cancer. Studies have found that EGCG can stop cancer cells from growing by blocking certain pathways in the cells and aiding the immune system in attacking cancer cells. In lab studies with mice, EGCG significantly reduced the size and weight of tumors. Additionally, EGCG seems to target cancer stem cells, which are often more difficult to treat. In this trial, participants in the EGCG arm will begin taking EGCG within 4-12 weeks of surgery. These findings suggest that EGCG could be an effective treatment option for colorectal cancer. ^{1 3 6 7 8}

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

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

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

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10164806/

Improving the anti-tumor effect of EGCG in colorectal ... Here we report that EGCG inhibits the tumor suppressive Hippo signaling pathway and activates downstream YAP in colorectal cancer (CRC) cells.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4941304/

Epigallocatechin-3-gallate targets cancer stem-like cells ... EGCG inhibits cancer stem cell formation in colorectal cancer cells ... These data indicate that EGCG treatment regulated expression of key miRNAs that control ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006291X24014438

Epigallocatechin-3-gallate induces immunogenic cell ... In this study, we document that EGCG, a novel ICD inducer, triggers ICD in colon cancer cells and reveal the potential of EGCG to treat cancer by regulating ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1756464623005777

Tea polyphenol EGC suppresses colorectal cancer cell ... Besides, in vivo study proved that EGC (100 mg/kg) resulted in significant suppression of tumor volume and tumor weight (decreased by 63.7 %) in mice bearing ...

5. mdpi.com mdpi.com/2072-6643/4/11/1679

Epigallocatechin Gallate (EGCG) Is the Most Effective ... Among the 10 polyphenols, EGCG showed the most potent antiproliferative effects, and significantly induced cell cycle arrest in the G1 phase and cell apoptosis.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1756464611001174

Protective effects of epigallocatechin gallate (EGCG) ... The results suggest that the lipophilic ester derivatives of EGCG are effective in inhibiting colon carcinogenesis and may be good candidates for colon cancer ...

7. oncotarget.com oncotarget.com/article/7567/text/

Epigallocatechin-3-gallate targets cancer stem-like cells ... Our data provide novel and previously unrecognized evidence for EGCG-induced sensitization to 5FU through targeting of CSCs in CRC.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11671467/

Epigallocatechin-3-gallate therapeutic potential in human ... In vivo studies demonstrated a significant reduction in both tumor growth and Notch1 expression in mice injected with EGCG. Similar findings ...