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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:
University of California, Los Angeles
Information provided by (Responsible Party):
Chao Family Comprehensive Cancer Center, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE November 17, 2005
First Posted Date  ICMJE November 21, 2005
Last Update Posted Date June 20, 2014
Study Start Date  ICMJE July 2005
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2007)
Test the hypothesis that resveratrol modulates Wnt signaling in vivo in colon cancer and normal colonic mucosa [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 17, 2005)
Test that resveratrol modulates Wnt signaling in vivo
Change History Complete list of historical versions of study NCT00256334 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resveratrol for Patients With Colon Cancer
Official Title  ICMJE Resveratrol for Patients With Colon Cancer
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colon Cancer
  • Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Resveratrol
GM-CSF administration to all subjects in addition to chemotherapy treatment.
Intervention: Drug: Resveratrol
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2011)
11
Original Enrollment  ICMJE
 (submitted: November 17, 2005)
6
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00256334
Other Study ID Numbers  ICMJE UCI 05-20
2005-4333 ( Other Identifier: University of California, Irvine )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chao Family Comprehensive Cancer Center, University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE University of California, Los Angeles
Investigators  ICMJE
Principal Investigator: Randall Holcombe, MD University of California, Irvine
PRS Account University of California, Irvine
Verification Date June 2014

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