Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Squamous Cell Carcinoma of Mouth, Intraepithelial Neoplasia
In brief
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.
Key facts
- Study ID
- NCT01192204
- Run by
- Ohio State University
- People needed
- 41
- Starts
- 2010-10-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2015-08-14
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Louisville, School of Dentistry — Louisville, Kentucky, United States
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- The Ohio State University, College of Dentistry — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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