A Phase 1b Pilot Study Evaluating Oral Administration of Freeze-Dried Black Raspberries in Pre-Surgical Patients With Oral Squamous Cell Carcinoma
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.
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).
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Relationship between the length of short-term LBR administration to human oral cancer patients and the modulation, in oral cavity tissues, of LBR-responsive genes
Statistical summaries of biopsy to surgery changes in quantitative real-time RT-PCR data made on the log scale (geometric mean of percent changes +/- s.e. expressed as a percentage).Confidence intervals produced and significance of the correlation between real-time RT-PCR values and period of treatment (i.e. time from biopsy to surgery) using Fisher's transformation of Spearman's rank correlation tested. Semi-quantitative IHC analyzed using an ordinal logistic model to determine significance of associations between period of treatment and change in staining from biopsy to surgery.
up to 60 months
Ohio State University
United States: Institutional Review Board
|Ohio State University Medical Center||Columbus, Ohio 43210|