A Chemopreventive Trial to Study the Effects of High Tea Consumption on Smoking-Related Oxidative Stress
Abstract
Our overall goal is to develop a safe and feasible model for the chemoprevention of a wide range of tobacco-related diseases. Our immediate goal, that is addressed over a 4-year study period, is to determine the effects of high tea consumption on biological markers of oxidative stress that mediate lung cancer risk. We are conducting a 6-month randomized, controlled, double-blinded chemopreventive trial in a group of COPD subjects who are being randomized to green or black tea preparations or a control intervention (matching placebo). Levels of 8-hydroxydeoxyguanosine and 8-F2-isoprostanes are used to measure DNA and lipid damage respectively. Changes in biomarkers of oxidative damage are being measured in urine, blood and exhaled breath condensate. The study protocol was approved by all parties in September 2003. Recruitment and screening of participants for eligibility criteria started in October 2003. By the end of December (2005), 200 participants signed the consent form and were screened for eligibility criteria (spirometry for lung function). A total of 187 subjects were eligible, however, 60 subjects dropped out during run-in and before randomization and 127 were randomized to one arm of the study. Currently 80 eligible subjects completed the study and 15 subjects are actively enrolled in the study. We expect that adherence to a regular pattern of tea is feasible and quantifiable among this high risk population.
Document Details
- Document Type
- Technical Report
- Publication Date
- Feb 01, 2006
- Accession Number
- ADA448863
Entities
People
- Iman A. Hakim
Organizations
- University of Arizona