Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

Defined Green Tea Catechin Extract in Preventing Esophageal Cancer in Patients With Barrett's Esophagus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00233935
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : September 11, 2014
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
The goal of this clinical research study is to test the safety of defined green tea catechin extract 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 Barrett's esophagus. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of defined green tea catechin extract may prevent esophageal cancer.

Condition or disease Intervention/treatment Phase
Barrett Esophagus Other: placebo Drug: defined green tea catechin extract Phase 1

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : November 2005
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Cianidanol

Arm Intervention/treatment
Experimental: Arm I (1 capsule)
Patients receive 1 capsule of defined green tea catechin extract PO BID for the next 6 months.
Drug: defined green tea catechin extract
Given PO
Other Name: Polyphenon E

Experimental: Arm II (2 capsules)
Patients receive 2 capsules of defined green tea catechin extract PO BID for the next 6 months.
Drug: defined green tea catechin extract
Given PO
Other Name: Polyphenon E

Experimental: Arm III (3 capsules)
Patients receive 3 capsules of defined green tea catechin extract PO BID for the next 6 months.
Drug: defined green tea catechin extract
Given PO
Other Name: Polyphenon E

Placebo Comparator: Arm IV (placebo)
Patients receive 1-3 capsules of placebo PO BID for the next 6 months.
Other: placebo
Given PO
Other Name: PLCB

Primary Outcome Measures :
  1. Toxicity defined according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (Version 3.0) [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. Dose-related biologic effects and pharmacodynamic properties of Poly E [ Time Frame: Up to 6 months ]
    Generalized linear models will be used.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically-confirmed diagnosis of Barrett's metaplasia within 12 months prior to trial entry
  • Note: The presence of LGD may be subject to disagreement between pathologists; this will not affect trial entry, since patients with or without LGD are eligible to participate; all cases in which there is disagreement regarding the presence of LGD will be reviewed by a third pathologist for histological classification prior to the efficacy analysis
  • Cases of short-segment (less than or equal to 3 cm) Barrett's esophagus must be large enough to allow adequate sampling of tissue without completely resecting the metaplasia
  • ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%)
  • Leukocytes greater than or equal to 3,000/UL
  • Absolute neutrophil count greater than or equal to 1,500/UL
  • Platelets greater than or equal to 100,000/UL
  • Total bilirubin within normal institutional limits
  • AST (SGOT)/ALT (SGPT) less than or equal to institutional ULN
  • Creatinine within normal institutional limits
  • Alkaline phosphatase less than or equal to the institutional ULN
  • Willingness to abstain from all tea consumption while on the study drug
  • Willingness to record intake of caffeine-containing foods and medications while on the study
  • A significant portion of caffeine intake occurs from "hidden" sources, including medications and foods
  • Study subjects will be provided a list of permissible medications, beverages and foods which contain caffeine
  • Participants may continue therapy with proton pump inhibitors, nonsteroidal anti-inflammatory agents, and celecoxib or rofecoxib
  • Pregnancy testing to within 2 weeks prior to randomization
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
  • If a female participant does become pregnant while on study, she will be removed from the study
  • Willingness to comply with all treatment and follow-up procedures
  • Willingness to wait at least one month since last endoscopic evaluation
  • Ability to understand and willingness to sign a written informed consent document
  • Inclusion of women and minorities: both men and women and members of all races and ethnic groups are eligible for this trial

Exclusion Criteria:

  • Histologically confirmed high-grade dysplasia
  • Histologically confirmed diagnosis of invasive carcinoma of the esophagus
  • Prior endoscopic therapy for Barrett's esophagus, including mucosal ablation, resection and esophagectomy, and photodynamic therapy
  • History of esophageal strictures with moderate-to-severe dysphagia or odynophagia that may interfere with ingestion/swallowing of the study drug
  • Trial participation will be determined by the study investigator after consideration of other factors including severity of dysphagia and odynophagia, necessity for treatment of strictures, and nutritional status
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Poly E
  • Participants may not be receiving any other investigational agents within 30 days prior to randomization or during the study
  • Use of medications, herbs, and vitamin and mineral supplements that contain tea compounds should not be taken while participating in the study and on study drug and for 30 days prior to trial entry
  • If patients are consuming any of these items and would like to participate in this study, then a 30-day voluntary washout will be required
  • Uncontrolled or significant co-morbid illness including, but not limited to, active or serious infection requiring intravenous antibiotics; symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia;
  • Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy, stage Ia grade 1 adenocarcinoma of the endometrium treated with surgery; patients receiving active chemotherapy or radiation; or psychiatric illness/social situations that would limit compliance with study requirements
  • Participants will not take aspirin, aspirin-containing substances, Coumadin (warfarin), heparin, or iron for 5 days before each endoscopy
  • Active gastrointestinal bleeding; predisposing condition to gastrointestinal bleeding (including but not limited to gastritis, diverticulitis, colitis, and hemorrhoids); active malignancy diagnosed or treated within 5 years, except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin, carcinoma in situ

Information from the National Library of Medicine

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 identifier (NCT number): NCT00233935

Layout table for location information
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Weill Medical College of Cornell University
New York, New York, United States, 10065
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Charles Lightdale Columbia University
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00233935    
Other Study ID Numbers: NCI-2009-00855
NCI-2009-00855 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2004-0907 ( Other Identifier: Columbia University Medical Center )
MDA03-1-01 ( Other Identifier: DCP )
N01CN35159 ( U.S. NIH Grant/Contract )
P30CA013696 ( U.S. NIH Grant/Contract )
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: September 11, 2014
Last Verified: April 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Barrett Esophagus
Precancerous Conditions
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Epigallocatechin gallate
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents