Resveratrol and Human Hepatocyte Function in Cancer

University of Louisville

Overview

The purpose of this study is to determine if Resveratrol, a nutritional supplement, shows a beneficial effect in the cellular function of normal liver cells and diseased liver cells (cancer cells) in samples of liver tissue taken during elective liver surgery. Outcomes based on 3 measures will test the hypothesis that Resveratrol when used as a nutritional supplement will 1)improve metabolic function in liver cells, 2)reduce cellular growth and proliferation of cancer cells, 3)decrease inflammation in the liver.

Hepatic function will be assessed by standard laboratory techniques. Hepatocyte signaling pathway proteins will be measured using western blot analysis for protein expression and polymerase chain reaction for gene expression. Activation of signaling pathways in both native hepatocytes and carcinoma will be analyzed by multi-plex signal array. The effect on transcription factors that may be important in gene expression will be analyzed by transcription factor array. The effect of resveratrol in altering hepatocyte and cancer cell metabolism will be analyzed by proteomic analysis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Conditions

Liver Cancer

Interventions

ResveratrolDIETARY_SUPPLEMENT

Resveratrol 1 gm po x 10 days prior to liver resection

PlaceboDRUG

Placebo 1 pill daily X 10 days

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Undergoing elective liver resection for liver cancer Exclusion Criteria: * Inability to speak or read English * Sclerosing cholangitis, hemochromatosis, hepatic encephalopathy, acute hepatic failure * History of daily alcohol intake * Presence of human immunodeficiency virus * Presence of significant renal dysfunction as defined by baseline serum creatinine \> 2.0 mg/dl or need/impending need for chronic dialysis therapy * Known allergy to the study medication * Pregnancy, lactating women, women contemplating pregnancy during the study period

Locations (1)

University of Louisville

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Improved metabolic profile of liver cells

This outcome is a composite outcome and will be measured by assessing expression of multiple signaling proteins that are important in hepatic cell metabolism such as Akt, p38, Mitogen Activated Kinases, and Adenosine Monophosphate-activated Kinase (AMPK) and expression of gluconeogenic proteins such as Phosphoenolpyruvate carboxykinase (PEPCK).

Time frame: 36 months

Secondary Outcomes

Decreased cell growth and proliferation

This outcome is a composite outcome of cellular pathways important in cancer cell replication. This will be measured by the expression of genes and proteins that regulate hepatic cell growth/cell survival such as cyclin gene expression, expression of the tumor suppressor p53, and expression of apoptosis proteins Bcl-2 and Bcl-xl.

Time frame: 36 months

Decreased hepatic inflammation

This outcome will be a composite outcome of pathways that regulate both cancer cell growth and inflammation. It will be measured by levels of genes and proteins for nitric oxide synthase, cytokines such as interleukin-6, and Nuclear Factor-kappa B signaling proteins.

Time frame: 36 months

Data from ClinicalTrials.gov

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