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Green Tea or Polyphenon E in Preventing Lung Cancer in Former Smokers With Chronic Obstructive Pulmonary Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of Arizona.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00363805
First received: August 10, 2006
Last updated: November 1, 2010
Last verified: November 2010
History of Changes
  Purpose

RATIONALE: Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of green tea or polyphenon E may prevent cancer from forming in former smokers with chronic obstructive pulmonary disease.

PURPOSE: This randomized phase II trial is studying how well green tea or polyphenon E work in preventing lung cancer in former smokers with chronic obstructive pulmonary disease.


Condition Intervention Phase
Lung Cancer
Pulmonary Complications
 Dietary Supplement: defined green tea catechin extract
Dietary Supplement: green tea
Other: placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Chemoprevention of Lung Carcinogenesis Using Green Tea: Phase IIb Randomized, Double-Blinded, Placebo Controlled Trial of Green Tea and Polyphenon E in Former Smokers With Chronic Obstructive Lung Disease (COPD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Biomarkers of cellular oxidative damage [ Designated as safety issue: No ]
  • Clinical improvement in pulmonary function [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modulation of gene expression in induced sputum [ Designated as safety issue: No ]

Estimated Enrollment: 195
Study Start Date: May 2004
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (green tea beverage)
Patients receive oral green tea beverage and oral polyphenon E placebo daily for 6 months.
 Dietary Supplement: green tea
Given orally
Experimental: Arm II (green tea capsule [polyphenon E])
Patients receive oral green tea beverage placebo and oral polyphenon E daily for 6 months.
 Dietary Supplement: defined green tea catechin extract
Given orally
Placebo Comparator: Arm III (placebo)
Patients receive oral green tea beverage placebo and oral polyphenon E placebo daily for 6 months.
 Other: placebo
Given orally

Detailed Description:

OBJECTIVES:

Primary

  • Evaluate the effects of high-level oral consumption of defined green tea (four 12-oz servings/day) or polyphenon E capsules (4 capsules/day) on markers of cellular oxidative damage, as measured by 8-hydroxydeoxyguanosine (8-OHdG) and 8-F_2-isoprostanes (8-epi-PGF2) in former smokers with chronic obstructive pulmonary disease.

Secondary

  • Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on body antioxidant status (carotenoids, vitamins A and E, ascorbic acid [vitamin C] and antioxidant enzymes [catalase and glutathione peroxidase]) in blood in these patients.
  • Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on gene expression of markers of proliferation (epidermal growth factor receptor [EGFR], proliferating cell nuclear antigen [PCNA], JUN, FOS, and Ki-67) and apoptosis (bcl-2 and caspase 3) in induced sputum in these patients.

Tertiary

  • Evaluate the effects of high-level oral consumption of defined green tea or polyphenon E capsules on lung function, in terms of FEV_1 and FVC improvement, in these patients.
  • Evaluate the relative adherence to use of green tea beverage vs polyphenon E capsules in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to gender and inhaled steroid usage (yes vs no).

All patients receive placebo tea beverage and placebo capsules 4 times a day for 2 weeks. Patients are randomized to 1 of 3 treatment arms after successful completion of the 2-week period.

  • Arm I (green tea beverage): Patients receive oral green tea beverage and oral polyphenon E placebo daily for 6 months.
  • Arm II (green tea capsule [polyphenon E]): Patients receive oral green tea beverage placebo and oral polyphenon E daily for 6 months.
  • Arm III (placebo): Patients receive oral green tea beverage placebo and oral polyphenon E placebo daily for 6 months.

Patients undergo blood, urine, exhaled breath condensate (EBC), induced sputum, and buccal cell collection at baseline and periodically during study for biomarker/laboratory analysis. Blood samples are analyzed for 8-hydroxydeoxyguanosine (8-OHdG), glutathione peroxidase, and catalase. Urine is examined for F_2-isoprostanes, 8-OHdG, and tea polyphenols. Induced sputum bronchoepithelial cells are analyzed for gene expression of genes implicated in cellular growth and apoptotic pathway (i.e., epidermal growth factor receptor [EGFR], proliferating cell nuclear antigen [PCNA], JUN, FOS, Ki-67, bcl-2, and caspase 3) via reverse transcriptase-polymerase chain reaction. EBC samples are examined for F_2-isoprostane levels. Buccal cells are stored for future analysis.

PROJECTED ACCRUAL: A total of 195 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of chronic obstructive pulmonary disease

    • FEV_1/FVC ≤ 78

  • History of smoking ≥ 1 pack daily for 30 years OR 2 packs daily for 15 years

    • Stopped smoking for ≥ 1 year
  • No previously diagnosed bronchiectasis
  • No history of > 1 acute emphysema exacerbation within the past 3 months

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • WBC ≥ 3,500/mm³
  • Platelet count > 130,000/mm³
  • Hemoglobin ≥ 11 g/dL (female) or 12 g/dL (male)
  • AST and ALT normal
  • Bilirubin ≤ 1.5 mg/dL (unless Gilbert's disease present)
  • Creatinine ≤ 1.5 mg/dL
  • Alkaline phosphatase ≤ 2 times upper limit of normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No invasive cancer within the past 5 years
  • Able and willing to consume caffeinated beverages
  • Able to produce induced sputum
  • Able to perform forced expiratory maneuver during spirometry testing

  • No immunosuppression by virtue of medication or disease including, but no limited to, any of the following:

    • Organ transplantation
    • Liver or kidney failure
    • Autoimmune diseases
    • Oral steroids
    • Chemotherapy
  • No serious concurrent illness that could preclude study compliance, such as uncontrolled high blood pressure, heart disease, or poorly controlled diabetes
  • No myocardial infarction within the past 6 weeks

PRIOR CONCURRENT THERAPY:

  • At least 2 weeks since prior and no concurrent dietary supplements or herbal products, including any of the following:

    • Herbal tea
    • Ginkgo biloba > 60 mg/day
    • Melatonin > 3 mg/day
    • Echinacea > 300 mg/day
    • Hypericum perforatum (St. John's wort) > 300 mg/day
    • DHEA mustard > 5 mg/day
  • At least 2 weeks since prior and no concurrent nontrial tea or tea products
  • More than 3 weeks since prior chest or abdominal surgery
  • More than 3 months since prior participation in chemoprevention or clinical intervention trials
  • At least 3 months since prior and no concurrent megadoses of vitamins, defined as > 4,000 IU of vitamin A, 400 IU of vitamin E, 400 IU of cholecalciferol (vitamin D), 60 μg of selenium, or 1,000 mg of ascorbic acid (vitamin C) per day
  • No regular consumption of ≥ 6 cups or glasses of tea per week
  • No concurrent nontrial caffeine at > 1 serving/day (1 serving defined as 12 oz of regular soda or 8 oz of coffee)
  • No concurrent participation in another interventional clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00363805

Locations
United States, Arizona
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724-5024
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States, 85723
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
Tucson, Arizona, United States, 85258
Sponsors and Collaborators
University of Arizona
National Cancer Institute (NCI)
Investigators
Principal Investigator: Iman Hakim, MD, PhD, MPH University of Arizona
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Iman Hakim, Arizona Cancer Center at University of Arizona Health Sciences Center
ClinicalTrials.gov Identifier: NCT00363805     History of Changes
Other Study ID Numbers: CDR0000487501, U01CA101204, P30CA023074, UARIZ-HSC-0353
Study First Received: August 10, 2006
Last Updated: November 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arizona:
small cell lung cancer
non-small cell lung cancer
pulmonary complications

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Neoplasms
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Epigallocatechin gallate
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 13, 2013