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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

Tracking Information
First Submitted Date  ICMJE August 30, 2010
First Posted Date  ICMJE August 31, 2010
Results First Submitted Date  ICMJE April 29, 2015
Results First Posted Date  ICMJE August 14, 2015
Last Update Posted Date August 14, 2015
Study Start Date  ICMJE October 2010
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2015)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2010)
Light microscopic diagnoses [ 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. 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 postreatment diagnosis.
Change History Complete list of historical versions of study NCT01192204 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2015)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2010)
  • clinical appearances and lesional sizes [ Time Frame: evaluated every 10-14 days throughout the duration of the trial ]
    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 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention
Official Title  ICMJE Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Squamous Cell Carcinoma of Mouth
  • Intraepithelial Neoplasia
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: 10% FBR containing bioadhesive gel
  • Placebo Comparator: Placebo Gel
    Color/consistency matched placebo (no black raspberry) gel
    Intervention: Drug: placebo gel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2015)
41
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2010)
72
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01192204
Other Study ID Numbers  ICMJE 2009C0086
RC2CA148099 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Susan Mallery DDS, PhD, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE
  • University of Louisville
  • University of North Carolina, Chapel Hill
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Susan R Mallery, DDS, PhD Ohio State University
PRS Account Ohio State University
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP