Resveratrol for Patients With Colon Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colon Cancer Cancer |
Drug: Resveratrol |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 ]
| Enrollment: | 11 |
| Study Start Date: | July 2005 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Resveratrol
GM-CSF administration to all subjects in addition to chemotherapy treatment.
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, California | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| Principal Investigator: | Randall Holcombe, MD | University of California, Irvine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Randall F. Holcombe, MD, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00256334 History of Changes |
| Other Study ID Numbers: | UCI 05-20, 2005-4333 |
| Study First Received: | November 17, 2005 |
| Last Updated: | August 15, 2011 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
|
Colon Cancer Resveratrol Clinical Trial |
WnT signaling Grapes Cancer prevention |
Additional relevant MeSH terms:
|
Resveratrol Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Antineoplastic Agents, Phytogenic Antineoplastic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Enzyme Inhibitors Platelet Aggregation Inhibitors Hematologic Agents |
ClinicalTrials.gov processed this record on June 18, 2013