Intraepithelial Neoplasia Clinical Trial
Official title:
Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention
Verified date | November 2013 |
Source | Ohio State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 80 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
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 | University of Louisville, School of Dentistry | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Ohio State University | National Cancer Institute (NCI), University of Louisville, University of North Carolina, Chapel Hill |
United States,
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* Note: There are 41 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Light Microscopic Histologically Scored Diagnoses Pretreatment to Post Treatment | A hemisection of lesional tissue will be conducted before the 3 month treatment to establish a diagnosis and provide a pretreatment baseline for the experimental parameters. Anl 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 to provide a posttreatment diagnosis. The 0 to 8 histologic scale was:0=normal with or without hyperkeratosis BEST OUTCOME, 1=atypia, 2=mild dysplasia, 3=mild-moderate dysplasia, 4=moderate dysplasia,5=moderate-severe dysplasia,6=severe dysplasia, 7=carcinoma in situ, 8=invasive oral squamous cell carcinoma (WORST OUTCOME). | Before and after the 3 month treatment. | No |
Secondary | Changes in Lesional Sizes | The remaining oral dysplasia lesion will be inspected at each follow up appointment (every 10-14 days). Biopsies will be immediately conducted on patients with any indication of malignant transformation including indurated, rolled borders, nonhealing ulcers, etc. Accordingly, these patients will withdraw from the trial. Participants will also be monitored for any changes consistent with contact mucositis e.g. soreness and erythema at application site. Clinical photographs were taken for the patients records. Pre treatment and post treatment photographs, with a ruler in place, were used for accurate pre and post treatment size measurement. NOTE: if treatment is beneficial, lesional size will decrease which will be reflected as a negative number. | pretreatment and posttreatment (3 months treatment duration) | No |
Secondary | Treatment Changes in Loss of Heterozygosity Events | Laboratory experiments will be conducted to assess the effects of gel treatment on pre and post loss of heterozygosity (LOH) events at loci associated with tumor suppressor genes. | Before and after the 3 month treatment duration | No |
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