Resveratrol for Patients With Colon Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Resveratrol for Patients With Colon Cancer|
- Test the hypothesis that resveratrol modulates Wnt signaling in vivo in colon cancer and normal colonic mucosa [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2005|
|Study Completion Date:||April 2009|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
GM-CSF administration to all subjects in addition to chemotherapy treatment.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256334
|United States, California|
|Chao Family Comprehensive Cancer Center|
|Orange, California, United States, 92868|
|Principal Investigator:||Randall Holcombe, MD||University of California, Irvine|