Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention

August 12, 2015 updated by: Susan Mallery DDS, PhD, Ohio State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 University, University of North Carolina at Chapel Hill and University of Louisville. 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.

In accordance with the established standard of care, all participants need to have biopsies taken of their suspicious oral lesions to establish the diagnosis (non research). Trial participants will have three total biopsies. Pretreatment biopsies will entail: 1) perilesional tissue and single saliva sample for FBR metabolic profiling studies (tissue and saliva will be obtained 15 minutes after a single 0.5 gm application of 10% FBR gel for metabolic profiling. Gel application and nonlesional biopsy will be obtained before incisional biopsy of lesional tissue), and 2) a hemisection of lesional tissue to establish a diagnosis and provide a pretreatment baseline for the experimental parameters. While the pretreatment biopsy includes removal of both perilesional and lesional tissue, there will only be one surgical wound as the perilesional tissue is contiguous with the lesional tissue. A final 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. The experimental design permits each patient to serve as their own internal control. Briefly, these following parameters will be monitored in all participants (comparisons made relative to patient-matched pretreatment to posttreatment biopsies): 1) light microscopic diagnoses, 2) clinical appearances and lesional sizes, 3) microarray gene expression analyses, 4) microvascular densities of superficial connective tissues, 5) LOH indices at loci associated with tumor suppressor genes, 6) intraepithelial levels of COX-2 and iNOS protein (image analysis quantified immunohistochemistry), 7) comparison of FBR metabolic profiles relative to extent of chemopreventive efficacy noted.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville, School of Dentistry
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
    • Ohio
      • Columbus, Ohio, United States, 43202
        • The Ohio State University, College of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 10% FBR containing bioadhesive gel
Drug consisting of 10% FBR containing bioadhesive gel. Participants instructed to apply 0.5 gm of 10% FBR containing bioadhesive gel four times a day to lesional site
Drug: 10% FBR containing bioadhesive gel
0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months
Other Names:
  • BRB gel
Placebo Comparator: Placebo Gel
Color/consistency matched placebo (no black raspberry) gel
Drug: placebo gel
0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months
Other Names:
  • BRB devoid placebo gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Light Microscopic Histologically Scored Diagnoses Pretreatment to Post Treatment
Time Frame: Before and after the 3 month 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Lesional Sizes
Time Frame: pretreatment and posttreatment (3 months treatment duration)
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)
Treatment Changes in Loss of Heterozygosity Events
Time Frame: Before and after the 3 month treatment duration
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

National Cancer Institute (NCI)
University of North Carolina, Chapel Hill
University of Louisville

Investigators

  • Principal Investigator: Susan R Mallery, DDS, PhD, Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

August 30, 2010

First Submitted That Met QC Criteria

August 30, 2010

First Posted (Estimate)

August 31, 2010

Study Record Updates

Last Update Posted (Estimate)

August 14, 2015

Last Update Submitted That Met QC Criteria

August 12, 2015

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009C0086
  • RC2CA148099 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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