Cancer Clinical Trial
Official title:
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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