Phase 2
N=41
Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention
Squamous Cell Carcinoma of Mouth · Intraepithelial Neoplasia
Bottom Line
View on ClinicalTrials.gov: NCT01192204 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Aug 2015
Primary outcome: Primary: Light Microscopic Histologically Scored Diagnoses Pretreatment to Post Treatment — 2.36; 2.83; 1.9; 2.58 unit on histologic grade scale — p=0.048
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 10% FBR containing bioadhesive gel (Drug); placebo gel (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Feb 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Light Microscopic Histologically Scored Diagnoses Pretreatment to Post Treatment |
2.36; 2.83; 1.9; 2.58 | 0.048 sig |
| SECONDARY Changes in Lesional Sizes |
-26.12; 18.12 | <0.002 sig |
| SECONDARY Treatment Changes in Loss of Heterozygosity Events |
0.9; 0.4 | 0.002 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Ages: 21 to 80
- Microscopically confirmed premalignant oral epithelial disease
- No previous history of cancer (with the exception of basal cell carcinoma of the skin)
- 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
- Availability for necessary study follow-up evaluations (every 10 to 14 days during the trial)
- Capable of providing informed consent.
Exclusion Criteria
- Previous history of cancer (with the exception of basal cell carcinoma of the skin)
- Current use of tobacco products or refusal to remain tobacco-free for the three month duration of the study
- Lack of microscopically confirmed premalignant oral epithelial changes
- Microscopic diagnosis of oral squamous cell carcinoma
- Previous history of radiation therapy on same side of the head and neck region
- History of allergy to any kind of berry
- Women who are determined to be pregnant or plan to be pregnant during the trial
- Women who are nursing.
Data sourced from ClinicalTrials.gov (NCT01192204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.