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

NCT00363805 | Completed Phase 2 Results

• 4 other identifiers: CDR0000487501U01CA101204P30CA023074UARIZ-HSC-0353
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Lung Cancer Prevention

Keywords

lung cancer; prevention; green tea; former smokers

Outcome Measures

Primary Outcomes (2)

• Change in Urinary 8-hydroxydeoxyguanosine Levels

  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

  Baseline and 6 months

• Change in Urinary 8-F2-isoprostanes Levels

  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

  Baseline and 6 months

Study Arms (3)

Green Tea

EXPERIMENTAL

Patients receive green tea beverage and placebo capsules for 6 months.

Dietary Supplement: green tea

Polyphenon E

EXPERIMENTAL

Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.

Drug: Polyphenon E

Placebo

PLACEBO COMPARATOR

Patients receive placebo beverage and placebo capsules daily for 6 months.

Other: placebo

Interventions

green tea DIETARY_SUPPLEMENT

Given orally

Green Tea

Polyphenon E DRUG

Given orally

Polyphenon E

placebo OTHER

Given orally

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sherry Chow: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea

Tucson, Arizona, 85258, United States

Location

Veterans Affairs Medical Center - Tucson

Tucson, Arizona, 85723, United States

Location

Arizona Cancer Center at University of Arizona Health Sciences Center

Tucson, Arizona, 85724-5024, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Smoking Cessation

Interventions

Tea; polyphenon E

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Results Point of Contact

• Title: Dr. Sherry Chow
• Organization: University of Arizona

schow@azcc.arizona.edu

520-626-3358

Study Officials

• Iman Hakim, MD, PhD, MPH

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: August 10, 2006
• First Posted: August 15, 2006
• Study Start: May 1, 2004
• Primary Completion: March 1, 2009
• Last Updated: November 28, 2013
• Results First Posted: November 28, 2013

Record last verified: 2013-09

Locations

US (3)