Back to resultsResveratrol and Human Hepatocyte Function in Cancer
Primary Purpose
Liver Cancer
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Resveratrol
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Liver Cancer focused on measuring Hepatocellular carcinoma, Metastatic colorectal cancer, Metabolism, Hepatic function
Eligibility 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
Sites / Locations
- University of Louisville
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
resveratrol
Placebo
Arm Description
Resveratrol 1 g daily for 10 days
Placebo 1 pill daily for 10 days
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02261844
Brief Title
Resveratrol and Human Hepatocyte Function in Cancer
Official Title
Resveratrol and Human Hepatocyte Function in Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
No funding
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Hepatocellular carcinoma, Metastatic colorectal cancer, Metabolism, Hepatic function
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
resveratrol
Arm Type
Experimental
Arm Description
Resveratrol 1 g daily for 10 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1 pill daily for 10 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Resveratrol
Other Intervention Name(s)
Biotivia
Intervention Description
Resveratrol 1 gm po x 10 days prior to liver resection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 1 pill daily X 10 days
Primary Outcome Measure Information:
Title
Improved metabolic profile of liver cells
Description
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).
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Decreased cell growth and proliferation
Description
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.
Time Frame
36 months
Title
Decreased hepatic inflammation
Description
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.
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian G Harbrecht, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
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Resveratrol and Human Hepatocyte Function in Cancer
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