EGCG for Colorectal Cancer
Trial Summary
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.
What evidence supports the effectiveness of the treatment EGCG for colorectal cancer?
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.13678
How is the drug EGCG unique in treating colorectal cancer?
Research Team
Sukeshi Patel, MD
Principal Investigator
CTRC (Cancer Therapy and Research Center) at UTHSCSA
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Blood draw prior to surgery, followed by surgical resection, and surgical pathologic specimen will be archived
Post-Surgery Evaluation
Patient will be seen in 4-12 weeks to determine if adjuvant chemotherapy is indicated
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
Follow-up
Colonoscopy will be done at 1 year from diagnosis, with normal colonic tissue biopsies and any resected polyps collected
Treatment Details
Interventions
- Epigallocatechin gallate (EGCG)
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San Antonio
Lead Sponsor