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Resveratrol and Human Hepatocyte Function in Cancer

University of Louisville (UOFL) logo

University of Louisville (UOFL)

Status and phase

Withdrawn
Phase 2
Phase 1

Conditions

Liver Cancer

Treatments

Drug: Placebo
Dietary Supplement: Resveratrol

Study type

Interventional

Funder types

Other

Identifiers

NCT02261844
ResveraCA

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups, including a placebo group

resveratrol
Experimental group
Description:
Resveratrol 1 g daily for 10 days
Treatment:
Dietary Supplement: Resveratrol
Placebo
Placebo Comparator group
Description:
Placebo 1 pill daily for 10 days
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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