Chemopreventive Effects of Epigallocatechin Gallate (EGCG) in Colorectal Cancer (CRC) Patients
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|ClinicalTrials.gov Identifier: NCT02891538|
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : September 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Drug: Epigallocatechin gallate (EGCG)||Early Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study to Evaluate the Chemopreventive Effects of Epigallocatechin Gallate (EGCG) in Colorectal Cancer (CRC) Patients With Curative Resections.|
|Actual Study Start Date :||January 31, 2017|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
Experimental: epigallocatechin gallate (EGCG)
Patients randomized to the EGCG arm, will start EGCG within 4-12 weeks of surgery and take EGCG 450 mg PO twice a day.
Drug: Epigallocatechin gallate (EGCG)
Teavigo™ is a natural, caffeine-free, highly purified and refined green tea extract providing 94% epigallocatechin gallate (EGCG).*
Other Name: Green Tea Extract
No Intervention: Observation Only
Standard of care surgical resection followed by standard of care colonoscopy at year.
- Change in methylation from baseline when compared to the control arm [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891538
|Contact: Epp Goodwinfirstname.lastname@example.org|
|Contact: Jay L Morris, PhDemail@example.com|
|United States, Texas|
|UT Health San Antonio||Recruiting|
|San Antonio, Texas, United States, 78229|
|Contact: Sukeshi P Arora, MD 210-450-2872|
|Principal Investigator:||Sukeshi Patel, MD||CTRC (Cancer Therapy and Research Center) at UTHSCSA|