What is the mechanism of action of this treatment?

Surgical resection, the physical removal of cancerous tissue, is a primary treatment for colon cancer. This method is crucial as it directly eliminates the primary tumor, reducing the risk of metastasis and providing immediate symptom relief. For patients with resectable colon cancer, surgical resection can be potentially curative, especially when combined with chemotherapy or radiotherapy to target any remaining cancer cells and minimize recurrence risk.

What side effects are associated with this type of intervention?

Common treatments for colon cancer, such as surgical resection and adjuvant chemotherapy, have several known side effects. Surgical resection can result in complications like infection, bleeding, and anesthesia-related issues. Adjuvant chemotherapy, which often includes drugs like oxaliplatin and fluorouracil, can cause neuropathy, diarrhea, nausea, vomiting, fatigue, and hand-foot syndrome. Long-term side effects may include persistent neuropathy and a temporary decrease in quality of life.

What prior FDA approvals exist?

The FDA has approved several treatments for colon cancer that are often used in conjunction with surgical resection. These include chemotherapeutic agents such as 5-fluorouracil (5-FU), oxaliplatin, and irinotecan, which are commonly used in adjuvant therapy to reduce the risk of cancer recurrence post-surgery. Targeted therapies like bevacizumab, cetuximab, and panitumumab have also been approved for use in specific cases of metastatic colorectal cancer, often in combination with chemotherapy. These treatments aim to improve surgical outcomes and overall survival rates in colon cancer patients.

What other types of research exist?

Promising novel alternatives to surgical resection for colon cancer patients in 2024 include: 1) Chemopreventive agents like Epigallocatechin Gallate (EGCG), which is being studied for its potential to prevent cancer progression. 2) Targeted therapies that focus on specific genetic mutations in cancer cells. 3) Immunotherapies that enhance the body's immune response to cancer. 4) Advanced radiotherapy techniques that precisely target cancer cells while sparing healthy tissue. These alternatives should be discussed with a healthcare provider to determine the best individualized treatment plan.

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Polyphenol

EGCG for Colorectal Cancer

Phase < 1

Waitlist Available

Led By Sukeshi Patel, MD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Cytologically or histologically confirmed of primary colon or rectal adenocarcinoma with resectable cancer, who have not received any treatments for cancer

Must not have

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

Patients with metastatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of EGCG aren't listed here, potential risks may include digestive issues due to its impact on absorption and allergic reactions similar to those from compounds in green tea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My recent blood tests meet the required levels for treatment.

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

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I agree to use two forms of birth control if I'm a woman not in menopause or surgically sterile, or a barrier method if I'm a man.

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I am eligible for surgery to remove my colorectal cancer without needing chemotherapy before surgery.

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My cancer has spread to other parts of my body.

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I have signed the consent form and understand the study procedures.

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I do not have stage III colon or rectal cancer.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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I have had chemotherapy or chemoradiation for colorectal cancer before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2022 Phase 1 trial • 39 Patients • NCT04177693

Headaches

Migraine after vaccine

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

EGCG Daily Alone.

EGCG With Clomiphene Citrate

EGCG With Letrozole

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: epigallocatechin gallate (EGCG)Experimental Treatment1 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 OnlyActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Epigallocatechin gallate (EGCG)

2020

Completed Phase 1

~40

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Surgical resection, the physical removal of cancerous tissue, is a primary treatment for colon cancer. This method is crucial as it directly eliminates the primary tumor, reducing the risk of metastasis and providing immediate symptom relief. For patients with resectable colon cancer, surgical resection can be potentially curative, especially when combined with chemotherapy or radiotherapy to target any remaining cancer cells and minimize recurrence risk.

Curative surgery for obstruction from primary left colorectal carcinoma: primary or staged resection?