Resveratrol and Human Hepatocyte Function in Cancer

Phase 1

Withdrawn

• Conditions: Liver Cancer
• Interventions: Dietary Supplement: Resveratrol; Drug: Placebo

• Registration Number: NCT02261844
• Lead Sponsor: University of Louisville

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-10
• Study Start: 2015-12
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
resveratrol	Resveratrol	Resveratrol 1 g daily for 10 days
Placebo	Placebo	Placebo 1 pill daily for 10 days

Primary Outcome Measures

Name	Time	Method
Improved metabolic profile of liver cells	36 months	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).

Secondary Outcome Measures

Name	Time	Method
Decreased hepatic inflammation	36 months	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.
Decreased cell growth and proliferation	36 months	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.

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States