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Clinical Trial Summary

This pilot phase I trial studies freeze-dried black raspberries in treating patients with oral squamous cell cancer undergoing surgery. Chemoprevention is the use of certain drugs to keep cancer from forming. Eating freeze-dried black raspberries may help prevent or treat oral cancer


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine the relationship between the length of short-term lyophilized black raspberries (LBR) administration to human oral cancer patients and the modulation, in oral cavity tissues, of a subset of specific genes previously identified by us to be "LBR-responsive" and associated with LBR's chemopreventive activity.

SECONDARY OBJECTIVES:

I. To evaluate the effects of LBR administration in humans on cell proliferation, apoptosis, and angiogenesis in oral cavity tissues using various established biomarkers including Ki-67 or proliferating cell nuclear antigen (PCNA), caspase-3, vascular endothelial growth factor (VEGF) or basic fibroblast growth factor (bFGF).

II. To assess the feasibility of administering lyophilized freeze-dried black raspberries in oral troche form to pre-surgical patients diagnosed with squamous cell carcinoma of the oral cavity (compliance, tolerance, adverse events). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01465776
Study type Interventional
Source Ohio State University Comprehensive Cancer Center
Contact
Status Completed
Phase N/A
Start date January 10, 2005
Completion date February 16, 2010

See also
  Status Clinical Trial Phase
Completed NCT01192204 - Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention Phase 1/Phase 2
Completed NCT01314755 - A Trial of Perioperative Immune Enhancing Feed in Patients Undergoing Surgery for Head and Neck Cancer N/A