Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention
Condition: Squamous Cell Carcinoma of Mouth; Intraepithelial Neoplasia
MeSH terms: Mouth Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed description: 
      Forty one (41) patients with microscopically confirmed premalignant oral epithelial disease
      (epithelial dysplasia) will be enrolled in this trial at three clinical centers, i.e. the
      Ohio State University, University of North Carolina at Chapel Hill and University of
      Louisville. 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.

      In accordance with the established standard of care, all participants need to have biopsies
      taken of their suspicious oral lesions to establish the diagnosis (non research). Trial
      participants will have three total biopsies. Pretreatment biopsies will entail: 1)
      perilesional tissue and single saliva sample for FBR metabolic profiling studies (tissue and
      saliva will be obtained 15 minutes after a single 0.5 gm application of 10% FBR gel for
      metabolic profiling. Gel application and nonlesional biopsy will be obtained before
      incisional biopsy of lesional tissue), and 2) a hemisection of lesional tissue to establish a
      diagnosis and provide a pretreatment baseline for the experimental parameters. While the
      pretreatment biopsy includes removal of both perilesional and lesional tissue, there will
      only be one surgical wound as the perilesional tissue is contiguous with the lesional tissue.
      A final excisional biopsy of the treatment site including any remaining residual lesional
      tissue (excision of oral dysplastic lesions is consistent with current standards of care)
      will be obtained after 3 months of treatment. The experimental design permits each patient to
      serve as their own internal control. Briefly, these following parameters will be monitored in
      all participants (comparisons made relative to patient-matched pretreatment to posttreatment
      biopsies): 1) light microscopic diagnoses, 2) clinical appearances and lesional sizes, 3)
      microarray gene expression analyses, 4) microvascular densities of superficial connective
      tissues, 5) LOH indices at loci associated with tumor suppressor genes, 6) intraepithelial
      levels of COX-2 and iNOS protein (image analysis quantified immunohistochemistry), 7)
      comparison of FBR metabolic profiles relative to extent of chemopreventive efficacy noted.
    

Intervention name(s): 10% FBR containing bioadhesive gel; placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months; 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months
Other intervention name(s): BRB gel; BRB devoid placebo gel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: FBR, OSCC, chemoprevention