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Resveratrol for Patients With Colon Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Colon Cancer, Cancer

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Trial Information

Resveratrol for Patients With Colon Cancer


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Test the hypothesis that resveratrol modulates Wnt signaling in vivo in colon cancer and normal colonic mucosa

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Randall Holcombe, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Irvine

Authority:

United States: Food and Drug Administration

Study ID:

UCI 05-20

NCT ID:

NCT00256334

Start Date:

July 2005

Completion Date:

April 2009

Related Keywords:

  • Colon Cancer
  • Cancer
  • Colon Cancer
  • Resveratrol
  • Clinical Trial
  • WnT signaling
  • Grapes
  • Cancer prevention
  • Colonic Neoplasms

Name

Location

Chao Family Comprehensive Cancer CenterOrange, California  92868