Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Louisville
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Susan Mallery DDS, PhD, Ohio State University
ClinicalTrials.gov Identifier:
NCT01192204
First received: August 30, 2010
Last updated: November 12, 2013
Last verified: November 2013
  Purpose

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 72 participants will be enrolled in this trial, and 24 of them will be enrolled at Ohio State. [The remaining 48 participants will be enrolled at the University of North Carolina (24 participants) and the University of Louisville (24 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.


Condition Intervention Phase
Oral Squamous Cell Carcinoma (OSCC)
Oral Epithelial Dysplasia
Drug: Bioadhesive 10% freeze-dried black raspberry gel
Drug: Color/consistency matched placebo gel
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Light microscopic diagnoses [ Time Frame: Before and after the 3 month treatment ] [ Designated as safety issue: No ]
    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. 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 to provide a posttreatment diagnosis.


Secondary Outcome Measures:
  • clinical appearances and lesional sizes [ Time Frame: evaluated every 10-14 days throughout the duration of the trial ] [ Designated as safety issue: No ]
    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.

  • Laboratory analyses [ Time Frame: Before and after the 3 month treatment duration ] [ Designated as safety issue: No ]
    Laboratory experiments will be conducted to analyze 1) microvascular densities of superficial connective tissues, 2) loss of heterozygosity (LOH) indices at loci associated with tumor suppressor genes, and 3)intraepithelial levels of COX-2 and iNOS protein (image analysis quantified immunohistochemistry)in lesional and perilesional tissues obtained from both pretreatment and posttreatment biopsies.


Estimated Enrollment: 72
Study Start Date: October 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 10% FBR gel
Active 10% FBR containing bioadhesive gel
Drug: Bioadhesive 10% freeze-dried black raspberry gel
0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months
Placebo Comparator: Placebo Gel
Color/consistency matched placebo (no black raspberry) gel
Drug: Color/consistency matched placebo gel
0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months

Detailed Description:

Seventy two 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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192204

Locations
United States, Kentucky
University of Louisville, School of Dentistry
Louisville, Kentucky, United States, 40202
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
The Ohio State University, College of Dentistry
Columbus, Ohio, United States, 43202
Sponsors and Collaborators
Ohio State University
University of Louisville
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Susan R Mallery, DDS, PhD Ohio State University
  More Information

Publications:

Responsible Party: Susan Mallery DDS, PhD, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01192204     History of Changes
Other Study ID Numbers: 2009C0086, RC2CA148099
Study First Received: August 30, 2010
Last Updated: November 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohio State University:
FBR, OSCC, chemoprevention

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Mouth Neoplasms
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 21, 2014