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Trial record 63 of 12357 for:    Oral Cancer
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Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention

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ClinicalTrials.gov Identifier: NCT01192204
Recruitment Status : Completed
First Posted : August 31, 2010
Results First Posted : August 14, 2015
Last Update Posted : August 14, 2015
Sponsor:
Collaborators:
University of Louisville
University of North Carolina, Chapel Hill
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Susan Mallery DDS, PhD, Ohio State University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Mouth Intraepithelial Neoplasia Drug: 10% FBR containing bioadhesive gel Drug: placebo gel Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention
Study Start Date : October 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer

Arms and Interventions
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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 Name: 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 Name: BRB devoid placebo gel


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01192204


Locations
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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
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Susan R Mallery, DDS, PhD Ohio State University
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Susan Mallery DDS, PhD, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01192204    
Other Study ID Numbers: 2009C0086
RC2CA148099 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2010    Key Record Dates
Results First Posted: August 14, 2015
Last Update Posted: August 14, 2015
Last Verified: November 2013
Keywords provided by Susan Mallery DDS, PhD, Ohio State University:
FBR, OSCC, chemoprevention
Additional relevant MeSH terms:
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Mouth Neoplasms
Neoplasms
Head and Neck Neoplasms
 Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases