NCT02719860

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2003

Typical duration for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
Last Updated

March 25, 2016

Status Verified

March 1, 2016

Enrollment Period

4.3 years

First QC Date

March 8, 2016

Last Update Submit

March 24, 2016

Conditions

Lung Cancer Prevention

Outcome Measures

Primary Outcomes (2)

  • Post-intervention change in urinary 8-hydroxydeoxyguanosine

    Baseline and 6 months

  • Post-intervention change in urinary 8-F2-isoprostanes

    Baseline and 6 months

Study Arms (3)

Green tea

EXPERIMENTAL
Dietary Supplement: Green tea

Black tea

EXPERIMENTAL
Dietary Supplement: Black tea

Placebo tea

PLACEBO COMPARATOR
Dietary Supplement: Placebo tea

Interventions

Green teaDIETARY_SUPPLEMENT

4 cups/day of green tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water

Green tea
Black teaDIETARY_SUPPLEMENT

4 cups/day of black tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water

Black tea
Placebo teaDIETARY_SUPPLEMENT

4 cups/day of placebo tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water

Placebo tea

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2016

First Posted

March 25, 2016

Study Start

September 1, 2003

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 25, 2016

Record last verified: 2016-03