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Sponsors and Collaborators: |
University of California, Irvine University of California, Los Angeles |
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Information provided by: | University of California, Irvine |
ClinicalTrials.gov Identifier: | NCT00256334 |
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, red wine and small amounts 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 will be performed to define the actions of resveratrol on the Wnt signaling pathway in a clinical trial in which patients with colon cancer will receive treatment with resveratrol and correlative laboratory studies will examine its effects directly on colon cancer and normal colonic mucosa.
These studies will provide data on the mechanisms of resveratrol action and provide a foundation for future prevention trials, correlative studies and therapeutic clinical research with this agent.
Condition | Intervention | Phase |
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Colon Cancer |
Drug: Resveratrol |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Resveratrol for Patients With Colon Cancer |
Estimated Enrollment: | 12 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center | 1-877-UC-STUDY | UCstudy@uci.edu |
United States, California | |
Chao Family Comprehensive Cancer Center | Recruiting |
Orange, California, United States, 92868 | |
Principal Investigator: Randall Holcombe, MD |
Principal Investigator: | Randall Holcombe, MD | Chao Family Comprehensive Cancer Center |
Responsible Party: | University of California, Irvine Chao Family Comprehensive Cancer Center ( Randall F. Holcombe, MD ) |
Study ID Numbers: | UCI 05-20 |
Study First Received: | November 17, 2005 |
Last Updated: | January 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00256334 History of Changes |
Health Authority: | United States: Institutional Review Board |
Colon Cancer |
Anti-Inflammatory Agents Anticarcinogenic Agents Digestive System Neoplasms Antioxidants Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Intestinal Neoplasms Resveratrol Digestive System Diseases |
Analgesics, Non-Narcotic Gastrointestinal Neoplasms Anti-Inflammatory Agents, Non-Steroidal Platelet Aggregation Inhibitors Peripheral Nervous System Agents Analgesics Antirheumatic Agents Colonic Neoplasms Antineoplastic Agents, Phytogenic Colorectal Neoplasms |
Anti-Inflammatory Agents Anticarcinogenic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Hematologic Agents Resveratrol Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics |
Digestive System Neoplasms Antimutagenic Agents Enzyme Inhibitors Intestinal Diseases Protective Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Analgesics, Non-Narcotic Gastrointestinal Neoplasms Platelet Aggregation Inhibitors Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |