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Resveratrol for Patients With Colon Cancer

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ClinicalTrials.gov Identifier: NCT00256334
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : June 20, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

November 17, 2005
November 21, 2005
June 20, 2014
July 2005
December 2008   (Final data collection date for primary outcome measure)
Test the hypothesis that resveratrol modulates Wnt signaling in vivo in colon cancer and normal colonic mucosa [ Time Frame: 3 years ]
Test that resveratrol modulates Wnt signaling in vivo
Complete list of historical versions of study NCT00256334 on ClinicalTrials.gov Archive Site
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Resveratrol for Patients With Colon Cancer
Resveratrol for Patients With Colon Cancer
Resveratrol is purported to possess cancer preventive activity, especially for colon cancer, though its mechanisms of action are not well defined. Resveratrol is found in the skin of grapes and has anti-oxidative and pro-apoptotic effects on cancer cell lines in vitro. The main dietary sources of resveratrol are grapes, grape products, and red wine, and small amounts may be found in mulberries. A prior report and compelling preliminary data from our laboratory suggest that resveratrol modulates Wnt signaling, a signaling pathway which is activated in over 85% of colon cancers. In this proposal, studies were performed to define the actions of resveratrol on the Wnt signaling pathway in a clinical trial in which patients with colon cancer received treatment with Resveratrol, and correlative laboratory studies examined its effects directly on colon cancer and normal colonic mucosa. These studies provided data on the mechanisms of resveratrol action and provided a foundation for future prevention trials, correlative studies and therapeutic clinical research with this agent.

Patients will be treated with a two-week course of resveratrol. The initiation of the treatment will be approximately 14 days before standard of care surgical resection of tumor. Resveratrol will be ingested as 20 mg pills or in the form of freeze-dried grape extract which is prepared by the California Table Grape Commission used under GMP guidelines for human consumption.

The first two patients receiving resveratrol will be treated at a dose of 20 mg/day, the third and fourth patients at a dose of 80 mg/day, and the fifth and sixth patients with a dose of 160 mg/day. All patients receiving grape extract will receive 125 mg/day that will have to be mixed with one 8 oz glass of water. There will be no dose adjustments. If a patient has any side effects which are attributed to the resveratrol, it will be discontinued.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Colon Cancer
  • Cancer
Drug: Resveratrol
Patients were randomly assigned to one of four dose cohorts: plant-derived resveratrol tablets (purchased through the Life Extension Foundation, Scottsdale, AZ) at a dose of 80 mg/day, plant-derived resveratrol tablets at a dose of 20 mg/day, Grape Powder (GP) dissolved in water and taken orally (supplied by the California Table Grape Commission) at a dose of 120 g/day, and GP at a dose of 80 g/day.
Experimental: Resveratrol
GM-CSF administration to all subjects in addition to chemotherapy treatment.
Intervention: Drug: Resveratrol
Nguyen AV, Martinez M, Stamos MJ, Moyer MP, Planutis K, Hope C, Holcombe RF. Results of a phase I pilot clinical trial examining the effect of plant-derived resveratrol and grape powder on Wnt pathway target gene expression in colonic mucosa and colon cancer. Cancer Manag Res. 2009 Apr 3;1:25-37.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
April 2009
December 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients diagnosed with colon cancer by colonoscopic biopsy and tissue obtained under UCI04-05.
  • Patients with a plan for surgical resection at UCIMC within 2-4 weeks of enrollment.

Exclusion Criteria:

  • Surgical resection to be performed at a facility other than UCIMC.
  • Patients under 18 years of age.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00256334
UCI 05-20
2005-4333 ( Other Identifier: University of California, Irvine )
Yes
Not Provided
Not Provided
Chao Family Comprehensive Cancer Center, University of California, Irvine
University of California, Irvine
University of California, Los Angeles
Principal Investigator: Randall Holcombe, MD University of California, Irvine
University of California, Irvine
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP