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

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).

Inclusion Criteria:

- Patients with newly diagnosed, biopsy-proven previously untreated squamous cell
carcinoma (SCC) of the oral cavity (stages I - IV); suspected cases of SCC will be
allowed if biopsy is performed and results of SCC confirmed on subsequent
histopathologic analysis (i.e. frozen section) prior to enrollment and initiation of
LBR administration

- Patients must already be planned for surgical resection of their tumor (prior to being
considered eligible for this study)

- Patients must be able to take nutrition/medications orally

- No prior history of intolerance or allergy to berry or berry-containing products

Exclusion Criteria:

- History of intolerance (including hypersensitivity or allergy) to berry or
berry-containing products

- Known history of bleeding disorder or patient on systemic anticoagulation therapy
(i.e. coumadin, heparin) for purposes of the study biopsy

- Pregnant women; although there are no known adverse effects of black raspberries upon
the fetus, if patients become pregnant during period of LBR administration, then LBR
will be discontinued and patient will be removed from the study

- Inability to grant informed consent

- Patients must not be planning to receive chemotherapy or radiation therapy prior to
their surgery or this will affect endpoint analysis and these patients will be
excluded from the study

- Patients taking cyclooxygenase (COX)-I or COX-2 inhibitors, who cannot be taken off
the medication due to their clinical condition will be excluded given that these
agents may interfere with biomarkers studied

- Vegetarians will be excluded from the study since we anticipate that this patient
population will have difficulty adhering to a low-phenolic diet (restricts basically
all plant-based foods)