Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention

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.

Sex

All

Minimum age

21 Years

Maximum age

80 Years

Inclusion Criteria:

1. Ages: 21 to 80
2. Microscopically confirmed premalignant oral epithelial disease
3. No previous history of cancer (with the exception of basal cell carcinoma of the skin)
4. Tobacco free for at least six weeks prior to entrance in the trial and remain tobacco-free for the three month duration of the study
5. Availability for necessary study follow-up evaluations (every 10 to 14 days during the trial)
6. Capable of providing informed consent.

Exclusion Criteria:

1. Previous history of cancer (with the exception of basal cell carcinoma of the skin)
2. Current use of tobacco products or refusal to remain tobacco-free for the three month duration of the study
3. Lack of microscopically confirmed premalignant oral epithelial changes
4. Microscopic diagnosis of oral squamous cell carcinoma
5. Previous history of radiation therapy on same side of the head and neck region
6. History of allergy to any kind of berry
7. Women who are determined to be pregnant or plan to be pregnant during the trial
8. Women who are nursing.

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