- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02261844
Resveratrol and Human Hepatocyte Function in Cancer
March 28, 2017 updated by: Brian G. Harbrecht, University of Louisville
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- University of Louisville
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: resveratrol
Resveratrol 1 g daily for 10 days
|
Resveratrol 1 gm po x 10 days prior to liver resection
Other Names:
|
PLACEBO_COMPARATOR: Placebo
Placebo 1 pill daily for 10 days
|
Placebo 1 pill daily X 10 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
36 months
|
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.
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian G Harbrecht, MD, University of Louisville
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2015
Primary Completion (ANTICIPATED)
June 1, 2016
Study Completion (ACTUAL)
June 1, 2016
Study Registration Dates
First Submitted
May 20, 2014
First Submitted That Met QC Criteria
October 6, 2014
First Posted (ESTIMATE)
October 10, 2014
Study Record Updates
Last Update Posted (ACTUAL)
March 30, 2017
Last Update Submitted That Met QC Criteria
March 28, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ResveraCA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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