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UMCC 2003-064 Resveratrol in Preventing Cancer in Healthy Participants (IRB 2004-535)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00098969
Recruitment Status : Completed
First Posted : December 9, 2004
Last Update Posted : December 17, 2012
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of resveratrol may prevent cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of resveratrol in preventing cancer in healthy participants.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: resveratrol Phase 1

Detailed Description:


  • Determine the concentration of resveratrol and its metabolites in the plasma, urine, and feces of healthy participants.
  • Correlate dose with systemic concentration of this drug and its metabolites in these participants.
  • Determine the safety of this drug in these participants.

OUTLINE: This is an open-label, dose-escalation, multicenter study.

Beginning 5 days before study drug administration, participants are put on a controlled diet (avoiding all resveratrol-containing food or drink) for washout. Participants receive oral resveratrol once on day 1.

Cohorts of 10 participants receive escalating doses of resveratrol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 10 participants experience dose-limiting toxicity. A total of 16 participants are treated at the MTD.

Participants are followed at 2 and 7 days.

PROJECTED ACCRUAL: A total of 10-40 participants will be accrued for this study within 6 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase I Single-Dose Safety and Phamacokinetics Clinical Study of Resveratrol AKA IRB 2003-424
Study Start Date : September 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • Healthy participants



  • 18 to 80

Performance status

  • WHO 0-1

Life expectancy

  • Not specified


  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count 120,000-450,000mm^3
  • Hemoglobin 10.5-17.5 g/dL for women OR 11.5-19.0 g/dL for men


  • Bilirubin 0.05-1.2 mg/dL
  • AST and ALT < 1.5 times normal


  • Creatinine normal
  • Urinalysis normal


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile participants must use effective contraception
  • Willing to abstain from ingesting large quantities of resveratrol-containing foods
  • Willing to spend 24 hours in the hospital
  • No cancer diagnosis that is currently under treatment, is clinically detectable, or that has been treated within the past 5 years except basal cell or squamous cell skin cancer
  • No concurrent excessive alcohol intake (>21 units per week for men; 14 units per week for women)


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Concurrent hormone replace ment therapy allowed
  • Concurrent oral or depot contraceptives allowed


  • Not specified


  • Not specified


  • At least 2 weeks since prior and no concurrent vitamin supplements of any type
  • More than 6 months since prior and no concurrent participation in any other experimental study
  • No other concurrent chronic medications, including over-the-counter medications, herbal/natural preparations, or dietary supplements
  • No other concurrent prescribed medication

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 identifier (NCT number): NCT00098969

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United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United Kingdom
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE2 7LX
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Dean E. Brenner, MD University of Michigan Rogel Cancer Center

Publications of Results:
Boocock DJ, Gescher AJ, Brown V, et al.: Phase I single-dose safety and pharmacokinetics clinical study of the potential cancer chemopreventive agent resveratrol. [Abstract] American Association for Cancer Research: 97th Annual Meeting, April 1-5, 2006, Washington, DC. 2006.

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00098969    
Other Study ID Numbers: CDR0000396464
P30CA046592 ( U.S. NIH Grant/Contract )
First Posted: December 9, 2004    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: March 2010
Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
Additional relevant MeSH terms:
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Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Antimutagenic Agents
Anticarcinogenic Agents