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Resveratrol and Human Hepatocyte Function in Cancer

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ClinicalTrials.gov Identifier: NCT02261844
Recruitment Status : Withdrawn (No funding)
First Posted : October 10, 2014
Last Update Posted : March 30, 2017
Sponsor:
Information provided by (Responsible Party):
Brian G. Harbrecht, 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.

Condition or disease Intervention/treatment Phase
Liver Cancer Dietary Supplement: Resveratrol Drug: Placebo Phase 1 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Resveratrol and Human Hepatocyte Function in Cancer
Study Start Date : December 2015
Estimated Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arm Intervention/treatment
Experimental: resveratrol
Resveratrol 1 g daily for 10 days
Dietary Supplement: Resveratrol
Resveratrol 1 gm po x 10 days prior to liver resection
Other Name: Biotivia

Placebo Comparator: Placebo
Placebo 1 pill daily for 10 days
Drug: Placebo
Placebo 1 pill daily X 10 days




Primary Outcome Measures :
  1. Improved metabolic profile of liver cells [ Time Frame: 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 :
  1. Decreased cell growth and proliferation [ Time Frame: 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.

  2. Decreased hepatic inflammation [ Time Frame: 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.



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261844


Locations
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Brian G Harbrecht, MD University of Louisville

Responsible Party: Brian G. Harbrecht, MD, University of Louisville
ClinicalTrials.gov Identifier: NCT02261844     History of Changes
Other Study ID Numbers: ResveraCA
First Posted: October 10, 2014    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017

Keywords provided by Brian G. Harbrecht, University of Louisville:
Hepatocellular carcinoma
Metastatic colorectal cancer
Metabolism
Hepatic function

Additional relevant MeSH terms:
Resveratrol
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents