1551 Double-blinded chemoprevention trial: berry gel shows efficacy relative to placebo

Saturday, March 24, 2012: 9:45 a.m. - 11 a.m.
Presentation Type: Poster Session
M. TONG1, B. HAN1, W. CHEN2, Y. LING2, Z. LIU2, A. CURRAN3, B.S. SHUMWAY4, G. KUSHNER5, G. BLAKEY III6, P. PEI1, G. STONER7, P. LARSEN2, and S. MALLERY1, 1College of Dentistry, Ohio State University, Columbus, OH, 2Ohio State University, Columbus, OH, 3School of Dentistry, University of North Carolina, Chapel Hill, NC, 4Department of Pharmacology and Toxicology, University of Louisville, Louisville, KY, 5Oral and Maxillofacial Surgery, University of Louisville, Louisville, KY, 6Oral & Maxillofacial Surgery, University of North Carolina, Chapel Hill, NC, 7Department of Medicine, Medical College of Wisconsin, Milwaukee, WI
Previous studies from our labs showed that topical application of a bioadhesive gel containing 10% w/w freeze dried black raspberries (BRB gel; applied 0.5 gm q.i.d.x 6wk) to lesions of oral epithelial dysplasia (OED) elicited positive effects including histologic and clinical regression, reduction in loss of heterozygosity (LOH) indices and COX-2 reduction.  These pilot studies, however, did not include a placebo gel (Pgel).

Objective: We are currently conducting a longer duration (3 months) double-blinded, placebo-controlled, multicenter chemoprevention trial that includes the previous evaluative parameters plus tissue metabolic profiling, and p16 methylation analyses.

Method: Twelve patients have completed the 3 month clinical trial to date (n=8 active, n=4 placebo). Evaluated parameters include: 1) clinical lesional area [normalized image size pixels to internal scale (ruler in photo)], 2) histopathology (2 board-certified oral pathologists).  All evaluations were conducted by an investigator(s) who was/were blinded to the patients’ gel group.

Result: BRB gel significantly reduced lesional size in 6 of 7 evaluable lesions (9.7% to 100%), with complete regression observed in 2 lesions (p=0.03, two-tailed, Wilcoxon signed-rank test). Conversely, Pgel treated lesions increased in area (n=4, increases ranged from 6.6% to 81.8%). Histologic comparisons of pre versus post tissues showed a significant post-treatment reduction in histologic grades in the BRB gel treated lesions (p=0.03, two-tailed, Wilcoxon signed-rank test); whereas no significant differences were detected in the Pgel treated tissues’ histopathology. Comparisons of post-treatment lesional areas of BRB gel relative to Pgel showed a significant difference (n=7 BRB gel, n=4 Pgel, p=0.02, two-tailed, Mann Whitney U).  Studies to assess effects on LOH indices, p16 methylation and metabolic profiling are ongoing.

Conclusion: These preliminary data validate the essential contribution of BRB constituents in OED chemoprevention and support our pilot trial data.

Supported by T32DE14320, R01CA129609, RC2CA148099, R21CA135478.

This abstract is based on research that was funded entirely or partially by an outside source: NIH: T32DE14320, R01CA129609, RC2CA148099, R21CA135478

Keywords: Cancer Chemoprevention, Oral biology, Oral medicine, Pathology and Therapeutics
See more of: Mucosal disease
See more of: Oral Medicine & Pathology