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

2016-09-07 16:23:21 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Colon Cancer

Intervention

Epigallocatechin gallate (EGCG)

Status

Not yet recruiting

Source

The University of Texas Health Science Center at San Antonio

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-09-07T16:23:21-0400

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Medical and Biotech [MESH] Definitions

The infusion of leaves of CAMELLIA SINENSIS (formerly Thea sinensis) as a beverage, the familiar Oriental tea, which contains CATECHIN (especially epigallocatechin gallate) and CAFFEINE.

Camellia sinensis L. (formerly Thea sinensis) is an evergreen Asiatic shrub of the THEACEAE family. The infusion of leaves of this plant is used as Oriental TEA which contains CAFFEINE; THEOPHYLLINE; and epigallocatechin gallate.

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

The segment of LARGE INTESTINE between the CECUM and the RECTUM. It includes the ASCENDING COLON; the TRANSVERSE COLON; the DESCENDING COLON; and the SIGMOID COLON.

The segment of LARGE INTESTINE between ASCENDING COLON and DESCENDING COLON. It passes from the RIGHT COLIC FLEXURE across the ABDOMEN, then turns sharply at the left colonic flexure into the descending colon.

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