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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00233935 |
Purpose
Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of Polyphenon E (green tea extract) may prevent esophageal cancer.
The goal of this clinical research study is to test the safety of Polyphenon E (Poly E) at different dose levels. Researchers also want to find out what effects, good and bad, it may have on individual and their risk for esophagus cancer. Esophagus cancer is an increased risk associated with Barret's Esophagus.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer Barrett's Esophagus |
Dietary Supplement: Polyphenon E (Poly E) Other: Placebo |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Patients With Barrett's Esophagus |
| Estimated Enrollment: | 55 |
| Study Start Date: | June 2006 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Poly E
3-5 capsules of oral green tea extract (Polyphenon E) twice daily
|
Dietary Supplement: Polyphenon E (Poly E)
3-5 capsules of oral green tea extract (Polyphenon E) twice daily for 6 months.
Other Name: defined green tea catechin extract
|
|
Placebo Comparator: Placebo
3-5 capsules of oral placebo twice daily.
|
Other: Placebo
3-5 capsules of oral placebo twice daily for 6 months.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Charles J. Lightdale, MD | Herbert Irving Comprehensive Cancer Center |
| Principal Investigator: | Andrew Joe, MD | Herbert Irving Comprehensive Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00233935 History of Changes |
| Other Study ID Numbers: | 2004-0907, CDR0000429486, MDA-03101, MDA-2004-0907, CPMC-AAA0407, N01-CN-35159 |
| Study First Received: | October 5, 2005 |
| Last Updated: | September 26, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Esophageal cancer Esophagus Precancerous/nonmalignant condition low-grade dysplasia |
LGD Polyphenon E Green Tea extract |
|
Barrett Esophagus Esophageal Diseases Esophageal Neoplasms Digestive System Abnormalities Digestive System Diseases Gastrointestinal Diseases |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms |