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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sherry Chow, University of Arizona
ClinicalTrials.gov Identifier:
NCT00363805
First received: August 10, 2006
Last updated: September 27, 2013
Last verified: September 2013
  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 Prevention
Dietary Supplement: green tea
Drug: Polyphenon E
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Change in Urinary 8-hydroxydeoxyguanosine Levels [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    the urinary concentrations of 8-hydroxydeoxyguanosine were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-hydroxydeoxyguanosine levels was calculated as the 6 months levels minus the baseline levels

  • Change in Urinary 8-F2-isoprostanes Levels [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
    the urinary concentrations of 8-F2-isoprostanes were normalized by the urinary creatinine concentrations to correct for variations in urine dilution/production and the change in urinary 8-F2-isoprostanes levels was calculated as 6 months levels minus baseline levels


Enrollment: 178
Study Start Date: May 2004
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Green Tea
Patients receive green tea beverage and placebo capsules for 6 months.
Dietary Supplement: green tea
Given orally
Experimental: Polyphenon E
Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
Drug: Polyphenon E
Given orally
Placebo Comparator: Placebo
Patients receive placebo beverage and placebo capsules 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 and apoptosis 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 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 broncho-epithelial cells are analyzed for gene expression of genes implicated in cellular growth and apoptotic pathway 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
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, see Learn About Clinical Studies.

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
Sherry Chow
Investigators
Principal Investigator: Iman Hakim, MD, PhD, MPH University of Arizona
  More Information

Additional Information:
No publications provided

Responsible Party: Sherry Chow, Research Professor, University of Arizona
ClinicalTrials.gov Identifier: NCT00363805     History of Changes
Other Study ID Numbers: CDR0000487501, U01CA101204, P30CA023074, UARIZ-HSC-0353
Study First Received: August 10, 2006
Results First Received: July 2, 2013
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arizona:
lung cancer
prevention
green tea
former smokers

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Lung Neoplasms
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014