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| ID | Type | Description | Link |
|---|---|---|---|
| 16-446H | Other Identifier | UT Health San Antonio |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| epigallocatechin gallate (EGCG) | Experimental | Patients randomized to the EGCG arm, will start EGCG within 4-12 weeks of surgery and take EGCG 450 mg PO twice a day. |
|
| Observation Only | No Intervention | Standard of care surgical resection followed by standard of care colonoscopy at year. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epigallocatechin gallate (EGCG) | Drug | Teavigoâ„¢ is a natural, caffeine-free, highly purified and refined green tea extract providing 94% epigallocatechin gallate (EGCG).* |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in methylation from baseline when compared to the control arm | 1 year |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sukeshi Patel, MD | CTRC (Cancer Therapy and Research Center) at UTHSCSA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Health San Antonio | San Antonio | Texas | 78229 | United States |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| C045651 | epigallocatechin gallate |
| D013662 | Tea |
| ID | Term |
|---|---|
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001628 | Beverages |
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|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D000066888 |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |