Evidence map›Paper›PMID 21680702›Full record

Trial reportCancer prevention research (Philadelphia, Pa.)2011

Phase I randomized, double-blind pilot study of micronized resveratrol (SRT501) in patients with hepatic metastases--safety, pharmacokinetics, and pharmacodynamics.

Lynne M Howells, D P Berry, P J Elliott, E W Jacobson, E Hoffmann, B Hegarty, K Brown, W P Steward, A J Gescher

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer prevention research (Philadelphia, Pa.), 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00920803 (A Phase 1, Double-Blind, Randomized Clinical Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SRT501 in Subjects With Colorectal Cancer and Hepatic Metastases), which is not on this map. Cited by 211 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
211citing papers in PubMed, 4 pooled it
8.8field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00920803 phase1completednot on this map

A Phase 1, Double-Blind, Randomized Clinical Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of SRT501 in Subjects With Colorectal Cancer and Hepatic Metastases

TypeinterventionalSponsorSirtris, a GSK CompanyRan2008 to 2009Enrolled9ConditionsNeoplasms, ColorectalArmsPlacebo, SRT501
3 · Its place in the literature

Who cites it

211 citing papers in PubMed, 4 syntheses or guidelines pooled it, 427 citations in OpenAlex.

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  20. The Therapeutic Potential ofMolecules (Basel, Switzerland) · 2025
    Article

151 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 2 institutions in 2 countries.

Lynne M HowellsCancer Biomarkers and Prevention Group, Department of Cancer Studies and Molecular Medicine, University of Leicester, Leicester, UK. lh28@le.ac.uk
D P Berry
P J Elliott
E W Jacobson
E Hoffmann
B Hegarty
K Brown
W P Steward
A J Gescher
Prevention Group · USUniversity of Leicester · GB

Funding

Cancer Research UK 13101Cancer Research UK A6894Cancer Research UK A7241Cancer Research UK C325/A6691Department of Health C325/A7241
6 · The paper itself

Abstract

The phytochemical resveratrol has undergone extensive preclinical investigation for its putative cancer chemopreventive properties. Low systemic availability of the parent compound due to rapid and extensive metabolism may confound its usefulness as a potential agent to prevent malignancies in organs remote from the site of absorption. Micronization allows increased drug absorption, thus increasing availability. Here we describe a pilot study of SRT501, micronized resveratrol, given as 5.0 g daily for 14 days, to patients with colorectal cancer and hepatic metastases scheduled to undergo hepatectomy. The purpose of the study was to assess the safety, pharmacokinetics, and pharmacodynamics of the formulation. SRT501 was found to be well tolerated. Mean plasma resveratrol levels following a single dose of SRT501 administration were 1,942 ± 1,422 ng/mL, exceeding those published for equivalent doses of nonmicronized resveratrol by 3.6-fold. Resveratrol was detectable in hepatic tissue following SRT501 administration (up to 2,287 ng/g). Cleaved caspase-3, a marker of apoptosis, significantly increased by 39% in malignant hepatic tissue following SRT501 treatment compared with tissue from the placebo-treated patients. SRT501 warrants further clinical exploration to assess its potential clinical utility.

Indexed as

AgedAntineoplastic Agents, PhytogenicCaspase 3Combined Modality TherapyDouble-Blind MethodFemaleHepatectomyHumansLiver NeoplasmsMaleMiddle AgedNeoplasm MetastasisPilot ProjectsPlacebosPostoperative ComplicationsResveratrolAntineoplastic Agents, PhytogenicCaspase 3PlacebosResveratrolStilbenesTitaniumtitanium dioxide

Identifiers

PMID21680702
PMCPMC3173869
OpenAlexW2148588414

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.