Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High-Risk Appalachian Patients Previously Treated With Surgery For Oral Cancer

PRIMARY OBJECTIVES:

I. To conduct an initial clinical study utilizing a high risk and underserved Appalachian
population who are former oral cancer patients to determine the practicability of long-term
daily lyophilized black raspberry (LBR) (LBR lozenge) administration and to gain insights
into the potential prevention of recurrent oral cancer by LBR.

SECONDARY OBJECTIVES:

I. Evaluate numerous parameters (recruitment, tolerability, adherence to study guidelines,
collection of biological samples, and demographics) that will be helpful in designing a
future definitive, randomized, Phase II or III clinical trial structured to assess the
potential effects of long-term LBR administration.

II. Evaluate the temporal modulation of LBR-responsive gene expression that favor oral cancer
chemoprevention in "at risk" normal tissues before, during and after LBR administration.

III. Assess the temporal modulation of LBR-responsive gene expression and biological levels
of fruit components in post-surgical oral cancer patients not exposed to LBR.

OUTLINE: Patients are assigned to 1 of 2 treatment arms.

ARM I: Patients receive lyophilized black raspberry lozenges orally (PO) 4 times daily (QID)
for 6 months.

ARM II: Patients do not receive lyophilized black raspberries lozenges.

After completion of study treatment, patients in Arm I are followed up for 5 years and
patients in Arm II are followed up for up to 1 year.

Inclusion Criteria:

- Patients from any Appalachian County with previously diagnosed, biopsy-proven,
surgically resected, oral squamous cell carcinoma (SCC) (stages T1 to T4), which
encompasses cancers of the oral cavity including lips, buccal mucosa, teeth, floor of
the mouth and gums and those of the oropharynx consisting of the base of the tongue,
soft palate, tonsillar area, and the posterior pharyngeal wall will be eligible

- Patients who have followed the advice of their physician and have been definitively
treated for their tumor by any method and are currently disease free will be eligible

- Patients may be enrolled as early as their first follow-up post-operative clinic visit
after their most recent surgery, but no more than 36 months post-surgery

- 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

- Patients who are actively receiving adjuvant therapy (radiation, chemotherapy) will be
excluded until such time as they have completed treatments

- 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