Resveratrol and Human Hepatocyte Function in Cancer

Liver Cancer Clinical Trial

Official title:

Resveratrol and Human Hepatocyte Function in Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02261844
• Other study ID #: ResveraCA
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: May 20, 2014
• Last updated: March 28, 2017
• Start date: December 2015
• Est. completion date: June 2016

Study information

• Verified date: March 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Dietary Supplement:
• Resveratrol
Resveratrol 1 gm po x 10 days prior to liver resection

Drug:
• Placebo
Placebo 1 pill daily X 10 days

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	36 months
Secondary	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.	36 months
Secondary	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.	36 months