Clinical trial · Interventional
UMCC 2003-064 Resveratrol in Preventing Cancer in Healthy Participants
Phase I Single-Dose Safety and Phamacokinetics Clinical Study of Resveratrol AKA IRB 2003-424
NCT00098969CI-TRIAL-00008684IRB 2004-535completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| resveratrol | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTBoocock 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.
- DERIVEDBrown 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 20935227