Resveratrol and Human Hepatocyte Function in Cancer

NCT02261844 | Withdrawn Phase 1

• 1 other identifier: ResveraCA
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer

Keywords

Hepatocellular carcinoma; Metastatic colorectal cancer; Metabolism; Hepatic function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Decreased cell growth and proliferation

  36 months

• Decreased hepatic inflammation

  36 months

Study Arms (2)

resveratrol

EXPERIMENTAL

Resveratrol 1 g daily for 10 days

Dietary Supplement: Resveratrol

Placebo

PLACEBO COMPARATOR

Placebo 1 pill daily for 10 days

Drug: Placebo

Interventions

Resveratrol DIETARY_SUPPLEMENT

Resveratrol 1 gm po x 10 days prior to liver resection

Also known as: Biotivia

resveratrol

Placebo DRUG

Placebo 1 pill daily X 10 days

Placebo

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing elective liver resection for liver cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular; Colorectal Neoplasms

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Officials

• Brian G Harbrecht, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: October 10, 2014
• Study Start: December 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 30, 2017

Record last verified: 2017-03

Locations

US (1)