Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256334
Status:
COMPLETED
Last Update Posted:
2014-06-20
First Post:
2005-11-17
Brief Title:
Resveratrol for Patients With Colon Cancer
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
Resveratrol for Patients With Colon Cancer
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgday the third and fourth patients at a dose of 80 mgday and the fifth and sixth patients with a dose of 160 mgday All patients receiving grape extract will receive 125 mgday 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
The first two patients receiving resveratrol will be treated at a dose of 20 mgday the third and fourth patients at a dose of 80 mgday and the fifth and sixth patients with a dose of 160 mgday All patients receiving grape extract will receive 125 mgday 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-4333 | OTHER | University of California Irvine | None |