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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02261844
Other study ID # ResveraCA
Secondary ID
Status Withdrawn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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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