Pilot Long-Term Oral Dose of Freeze-Dried Black Raspberries in Post-Surgical Appalachian 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.
Interventional
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
No
Amit Agrawal, MD
Principal Investigator
Ohio State University
United States: Institutional Review Board
OSU-06132
NCT01504932
February 2007
Name | Location |
---|---|
Ohio State University Medical Center | Columbus, Ohio 43210 |