← Back to Search

Polyphenol

EGCG for Colorectal Cancer

Phase < 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is for patients with colon or rectal cancer who haven't received any treatment yet. If they're eligible for surgery, they'll be enrolled and given the chance to either have surgery alone or surgery with a new type of chemotherapy.

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.Check my eligibility
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.See study design
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
Select...
My recent blood tests meet the required levels for treatment.
Select...
My colon or rectal cancer is confirmed and treatable but I haven't received any cancer treatments yet.
Select...
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.
Select...
I am eligible for surgery to remove my colorectal cancer without needing chemotherapy before surgery.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in methylation from baseline when compared to the control arm

Side effects data

From 2022 Phase 1 trial • 39 Patients • NCT04177693
6%
Headaches
6%
Migraine after vaccine
6%
Diarrhea
100%
80%
60%
40%
20%
0%
Study treatment Arm
EGCG Daily Alone.
EGCG With Clomiphene Citrate
EGCG With Letrozole

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

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,378 Total Patients Enrolled
Sukeshi Patel, MD5.01 ReviewsPrincipal Investigator - CTRC (Cancer Therapy and Research Center) at UTHSCSA
The University of Texas Health Science Center at San Antonio

Media Library

Colon Cancer Research Study Groups: epigallocatechin gallate (EGCG), Observation Only

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other experiments that have been conducted utilizing Epigallocatechin gallate (EGCG)?

"Currently, 3 clinical trials are in-progress that investigate Epigallocatechin gallate (EGCG) with none being at the Phase 3 stage. Despite this, there are a total of 296 research facilities across the world conducting these studies, most notably in Fort Collins, Colorado."

Answered by AI

Are there any available opportunities for participants in this experiment?

"Affirmative. As per the information on clinicaltrials.gov, this study is actively seeking participants and was initially listed in January 31st 2017 with its most recent update being December 13th 2021. The sample size consists of 50 patients from a single location."

Answered by AI

How many people is this study recruiting?

"Affirmative. The clinical trial registry hosted on clinicaltrials.gov discloses that the study, which was first posted on January 31st 2017, is now actively recruiting 50 participants from 1 different medical site."

Answered by AI
~3 spots leftby Sep 2024