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Status:

COMPLETED

UMCC 2003-064 Resveratrol in Preventing Cancer in Healthy Participants

Lead Sponsor:

National Cancer Institute (NCI)

Conditions:

Unspecified Adult Solid Tumor, Protocol Specific

Eligibility:

All Genders

18-80 years

Phase:

PHASE1

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 sid...

Detailed Description

OBJECTIVES: * 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...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Healthy participants
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 to 80
  • Performance status
  • WHO 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • 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
  • Hepatic
  • Bilirubin 0.05-1.2 mg/dL
  • AST and ALT \< 1.5 times normal
  • Renal
  • Creatinine normal
  • Urinalysis normal
  • Other
  • 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)
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • Not specified
  • Chemotherapy
  • Not specified
  • Endocrine therapy
  • Concurrent hormone replace ment therapy allowed
  • Concurrent oral or depot contraceptives allowed
  • Radiotherapy
  • Not specified
  • Surgery
  • Not specified
  • Other
  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    40 Patients enrolled

    Trial Details

    Trial ID

    NCT00098969

    Start Date

    September 1 2004

    Last Update

    December 17 2012

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, United States, 48109-0942

    2

    Leicester Royal Infirmary

    Leicester, England, United Kingdom, LE2 7LX