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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | 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: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Patients With Barrett's Esophagus |
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2006 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Poly E: Experimental
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.
|
|
Placebo: Placebo Comparator
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 | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615 | |
| New York Weill Cornell Cancer Center at Cornell University | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U 713-792-3245 | |
| 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: | UT MD Anderson Cancer Center ( Robert S. Bresalier, MD / Professor ) |
| Study ID Numbers: | 2004-0907, CDR0000429486, MDA-03101, MDA-2004-0907, CPMC-AAA0407 |
| Study First Received: | October 5, 2005 |
| Last Updated: | October 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00233935 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Esophageal cancer Esophagus Precancerous/nonmalignant condition low-grade dysplasia |
LGD Polyphenon E Green Tea extract |
|
Neoplasms Neoplasms by Site Digestive System Neoplasms Digestive System Diseases Digestive System Abnormalities Gastrointestinal Diseases |
Head and Neck Neoplasms Esophageal Neoplasms Gastrointestinal Neoplasms Barrett Esophagus Esophageal Diseases |