NCT02891538

Chemopreventive Effects of Epigallocatechin Gallate (EGCG) in Colorectal Cancer (CRC) Patients

A Pilot Study to Evaluate the Chemopreventive Effects of Epigallocatechin Gallate (EGCG) in Colorectal Cancer (CRC) Patients With Curative Resections.

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a randomized, controlled pilot trial of patients with histological documentation of primary colon or rectal adenocarcinoma with resectable cancer, who have not received any treatments for cancer. If patient is a candidate for surgical resection, with no planned neoadjuvant chemotherapy, then the patient is eligible. All eligible subjects will be consented prior to surgery.

Detailed description

Part 1: Blood draw prior to surgery, followed by surgical resection, and surgical pathologic specimen will be archived. After surgery, patient will be seen in 4-12 weeks to determine if adjuvant chemotherapy is indicated, in which case patient will receive adjuvant therapy. At this visit a blood draw will be done. Part 2: If the patient is stage 0/1/2 and no plan for adjuvant treatments, then the patient will be randomized in a 2:1 manner to EGCG 900 mg daily vs observation (standard of care) for 1 year. Patients randomized to the EGCG arm, will start EGCG within 4-12 weeks of surgery and take EGCG 450 mg PO twice a day. Blood draw will be done at 0, 3, 6, 9, 12, 15, 18 months. Colonoscopy will be done at 1 year from diagnosis, at which time normal colonic tissue biopsies as well as any resected polyps will be collected.

Conditions

• Colon Cancer

Interventions

Type	Name	Description
DRUG	Epigallocatechin gallate (EGCG)	Teavigo™ is a natural, caffeine-free, highly purified and refined green tea extract providing 94% epigallocatechin gallate (EGCG).\*

Timeline

• Start date: 2017-01-31
• Primary completion: 2024-12-02
• Completion: 2025-12-02
• First posted: 2016-09-07
• Last updated: 2025-09-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study