High Tea Consumption on Smoking Related Oxidative Stress

A Chemoprevention Trial to Study the Effects of High Tea Consumption on Smoking Related Oxidative Stress

The overall objective of this study is to determine the effect of high tea consumption on biological markers of oxidative stress that mediate lung cancer risk.

Study Overview

• Status: Completed
• Conditions: Lung Cancer Prevention
• Intervention / Treatment: Dietary supplement: Green tea; Dietary supplement: Black tea; Dietary supplement: Placebo tea

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• FEV1 < 85% and at least 25 pack-years of current or former smoking history.
• No diagnosis of internal cancer within the last 5 years or no chemotherapy or radiation for an internal cancer within the last 5 years.
• Meets the Southwest Oncology Group (SWOG) performance status criteria of 0-1.
• Not be pregnant or intending to get pregnant during the study period (women participants).
• Willing to drink 4 cups of tea (each cup will be brewed with 2 tea bags and 12 ounces of water) for 1-month run-in period and for the 6-month intervention period.
• Willing to refrain from consuming other tea or tea products starting one month before the placebo run-in period and for the entire study period (a total of 8 months)
• Willing to refrain from consuming more than one caffeinated product (coffee, soda..) starting one month before the placebo run-in period and for the entire study period (a total of 8 months).
• Subjects cannot take mega-doses of vitamins during the trial. This is defined as more than 400 IU of vitamin E, 200 ug of selenium, or 1 gm of vitamin C per day, or more than the tolerable upper limits of any other supplement as defined in the Dietary Reference Intake panels developed by the Food and Nutrition Board under the Institute of Medicine. Such vitamin therapy must be discontinued at least 2 weeks prior to study entry.

Exclusion Criteria:

• Subjects immunosuppressed by virtue of medication or disease.
• Serious concurrent illness that could interfere with study regimen.
• Subjects with a history of invasive cancer within the past 5 years.
• Subjects who are drinking more than 5 cups of non-herbal tea per week.
• Subjects who cannot or are unwilling to consume caffeinated beverages.
• Subjects unable to perform forced expiratory maneuver during spirometry testing.
• More than one acute emphysema exacerbation within the last 6 month -period .
• Subjects on oxygen.
• Women with positive urinary pregnancy test.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Green tea	Dietary supplement: Green tea; 4 cups/day of green tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water
EXPERIMENTAL: Black tea	Dietary supplement: Black tea; 4 cups/day of black tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water
PLACEBO_COMPARATOR: Placebo tea	Dietary supplement: Placebo tea; 4 cups/day of placebo tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post-intervention change in urinary 8-hydroxydeoxyguanosine	Baseline and 6 months
Post-intervention change in urinary 8-F2-isoprostanes	Baseline and 6 months

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start: September 1, 2003
• Primary Completion (ACTUAL): December 1, 2007
• Study Completion (ACTUAL): December 1, 2007

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: March 24, 2016
• First Posted (ESTIMATE): March 25, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): March 25, 2016
• Last Update Submitted That Met QC Criteria: March 24, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 03-0014