Pilot Long-Term Oral Dose of Freeze-Dried Black Raspberries in Post-Surgical Appalachian Oral Cancer
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.
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
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Time to recurrence
Two side tests and confidence intervals will be constructed using the exact binomial formulation.
Up to 5 years
Amit Agrawal, MD
Ohio State University
United States: Institutional Review Board
|Ohio State University Medical Center||Columbus, Ohio 43210|