Resveratrol and Human Hepatocyte Function in Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liver Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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resveratrol

Resveratrol 1 g daily for 10 days

Group Type EXPERIMENTAL

Resveratrol

Intervention Type DIETARY_SUPPLEMENT

Resveratrol 1 gm po x 10 days prior to liver resection

Placebo

Placebo 1 pill daily for 10 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 1 pill daily X 10 days

Interventions

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Resveratrol

Resveratrol 1 gm po x 10 days prior to liver resection

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo 1 pill daily X 10 days

Intervention Type DRUG

Other Intervention Names

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Biotivia

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No