Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention

NCT ID: NCT01192204

Last Updated: 2015-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2014-02-28

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 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.

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.

Conditions

Squamous Cell Carcinoma of Mouth; Intraepithelial Neoplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

10% FBR containing bioadhesive gel

Intervention Type: DRUG

0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months

Placebo Gel

Color/consistency matched placebo (no black raspberry) gel

Group Type: PLACEBO_COMPARATOR

placebo gel

Intervention Type: DRUG

0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months

Interventions

10% FBR containing bioadhesive gel

0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months

Intervention Type: DRUG

placebo gel

0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months

Intervention Type: DRUG

Other Intervention Names

BRB gel; BRB devoid placebo gel

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Susan Mallery DDS, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan R Mallery, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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

Countries

United States

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Other Identifiers

RC2CA148099

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2009C0086

Identifier Type: -

Identifier Source: org_study_id