Spots Global Cancer Trial Database for Freeze-Dried Black Raspberries in Treating Patients With Oral Squamous Cell Cancer Undergoing Surgery

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Trial Identification

Brief Title: Freeze-Dried Black Raspberries in Treating Patients With Oral Squamous Cell Cancer Undergoing Surgery

Official Title: A Phase 1b Pilot Study Evaluating Oral Administration of Freeze-Dried Black Raspberries in Pre-Surgical Patients With Oral Squamous Cell Carcinoma

Study ID: NCT01465776

Conditions

Squamous Cell Carcinoma of Mouth

Interventions

laboratory biomarker analysis

preventative dietary intervention

Study Description

Brief 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

Detailed 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).