Status:
COMPLETED
Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
University of Louisville
University of North Carolina, Chapel Hill
Conditions:
Squamous Cell Carcinoma of Mouth
Intraepithelial Neoplasia
Eligibility:
All Genders
21-80 years
Phase:
PHASE1
PHASE2
Brief 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 tr...
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 Univers...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01192204
Start Date
October 1 2010
End Date
February 1 2014
Last Update
August 14 2015
Active Locations (3)
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1
University of Louisville, School of Dentistry
Louisville, Kentucky, United States, 40202
2
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
3
The Ohio State University, College of Dentistry
Columbus, Ohio, United States, 43202