NCT00098969

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2004

Completed
Last Updated

December 17, 2012

Status Verified

March 1, 2010

First QC Date

December 8, 2004

Last Update Submit

December 13, 2012

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

resveratrolDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Leicester Royal Infirmary

Leicester, England, LE2 7LX, United Kingdom

Location

Related Publications (2)

  • 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.

    RESULT

  • Brown VA, Patel KR, Viskaduraki M, Crowell JA, Perloff M, Booth TD, Vasilinin G, Sen A, Schinas AM, Piccirilli G, Brown K, Steward WP, Gescher AJ, Brenner DE. Repeat dose study of the cancer chemopreventive agent resveratrol in healthy volunteers: safety, pharmacokinetics, and effect on the insulin-like growth factor axis. Cancer Res. 2010 Nov 15;70(22):9003-11. doi: 10.1158/0008-5472.CAN-10-2364. Epub 2010 Oct 8.

    PMID: 20935227DERIVED

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • Dean E. Brenner, MD

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

December 8, 2004

First Posted

December 9, 2004

Study Start

September 1, 2004

Last Updated

December 17, 2012

Record last verified: 2010-03

Locations

US(1)GB(1)