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Resveratrol for Patients With Colon Cancer
This study is currently recruiting participants.
Verified by University of California, Irvine, January 2009
First Received: November 17, 2005   Last Updated: January 2, 2009   History of Changes
Sponsors and Collaborators: University of California, Irvine
University of California, Los Angeles
Information provided by: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00256334
  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, 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
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

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • 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 ]

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)
Intervention Details:
    Drug: Resveratrol
    The first two patients receiving resveratrol pills will be treated at a dose of 20mg/day, the third and fourth patients at a dose of 80mg/day and the fifth and sixth patients at a dose of 160mg/day
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00256334

Contacts
Contact: Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center 1-877-UC-STUDY UCstudy@uci.edu

Locations
United States, California
Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Principal Investigator: Randall Holcombe, MD            
Sponsors and Collaborators
University of California, Irvine
University of California, Los Angeles
Investigators
Principal Investigator: Randall Holcombe, MD Chao Family Comprehensive Cancer Center
  More Information

No publications provided

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

Keywords provided by University of California, Irvine:
Colon Cancer

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 11, 2009