The Effect of Berries on Lung Cancer Tumors
The purpose of this study is to determine how berries affect cancer tumors in patients with non-small cell lung cancer.
|Study Design:||Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Berry Interventional Trial (BIT) in Resected Non-Small Cell Lung Cancer|
- Assessment of blueberry and black raspberry phenolics in plasma and urine [ Time Frame: upon completion of 4 to 5 weeks of daily consumption of berry powder ] [ Designated as safety issue: No ]In addition to determining the berry phytochemical profile in plasma and urine, this study will attempt to establish the effect of berries on modulating immunological profiles such as the complete blood count, and T, B and natural killer (NK) cell populations and circulating biomarkers (serum proteins and microRNAs). This pilot study will establish the safety and feasibility of conducting a larger clinical trial with berry intervention.
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Dietary Supplement: berry powder
All subjects (lung cancer survivors and volunteers) will consume 20 grams of berry powder (blueberries, black raspberries, or a mixture of both) per day by mouth for the first 3 days, then 40 grams of berry powder by mouth every day for 4 to 5 weeks.
The berry powder is to be mixed in subject's routine intake of milk, yogurt, juice, or water.
All subjects will have the option to continue the berry regimen for an extended period. Subjects who choose to do so will not consume any berry powder for one week. After one week, subjects will begin consuming 40 grams of the berry powder every day for an additional 4 to 5 weeks.
In the United States, more people (161,840 per year) die of lung cancers than of prostate cancer, breast cancer and colon cancer combined. Presently, there are over 43 million current smokers and over 47 million ex-smokers living in the US. Due to the lag time between smoking and the development of cancer, there are significant numbers of ex-smokers and current smokers who may develop lung cancer compared to never smokers.
Recent studies in animals have shown that berries, given as a dietary supplement, are highly effective against certain types of cancers. In a study involving mice with lung tumors, mice that had consumed a mixture of berries developed fewer tumors and had less tumor growth than mice that did not consume berries.
The berries used in this study will consist of blueberries, black raspberries, or a mixture of both.
|Contact: Radha Munagala||(502) email@example.com|
|United States, Kentucky|
|James Graham Brown Cancer Center||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator: Ramesh Gupta, PhD|
|Principal Investigator:||Ramesh Gupta, PhD||James Graham Brown Cancer Center|