Berry Interventional Trial (BIT) in Resected Non-Small Cell Lung Cancer
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
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Assessment of blueberry and black raspberry phenolics in plasma and urine
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.
upon completion of 4 to 5 weeks of daily consumption of berry powder
Ramesh Gupta, PhD
James Graham Brown Cancer Center
United States: Institutional Review Board
|James Graham Brown Cancer Center||Louisville, Kentucky 40202|