Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention
Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
Participant gender:
Summary
This is a multicenter placebo-controlled clinical trial to assess the effects of a topically
applied gel on precancerous oral epithelial lesions. A total of 41 participants will be
enrolled in this trial, and 22 of them will be enrolled at Ohio State. [The remaining 19
participants will be enrolled at the University of North Carolina (9 participants) and the
University of Louisville (8 participants)]. At all three institutions, half of the
participants will randomly be assigned to the 10% FBR gel (0.5 gm four times daily for 3
months), while half will enter the placebo control arm. All trial participants will have a
pretreatment (including lesional and perilesional tissue) biopsy taken before and an
excisional biopsy after 3 months of treatment. As pretreatment indices are compared to post
treatment effects on each patient, patients serve as their own internal control. Pretreatment
lesional biopsies are obtained to establish a pretreatment diagnosis and provide a
pretreatment baseline for the experimental parameters.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Ohio State University
Collaborators:
National Cancer Institute (NCI) University of Louisville University of North Carolina, Chapel Hill