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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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions Squamous Cell Carcinoma of Mouth
Intraepithelial Neoplasia
Interventions Drug: 10% FBR containing bioadhesive gel
Drug: placebo gel
Enrollment 41
Recruitment Details  
Pre-assignment Details 41 patients were enrolled in this protocol. 1 patient could not keep the appointments and was referred to his private oral surgeon.
Arm/Group Title 10% FBR Gel Placebo Gel
Hide Arm/Group Description

Active 10% FBR containing bioadhesive gel

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

Color/consistency matched placebo (no black raspberry) gel

Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months

Period Title: Overall Study
Started 23 18
Completed 22 18
Not Completed 1 0
Reason Not Completed
could not keep recall appointments             1             0
Arm/Group Title 10% FBR Gel Placebo Gel Total
Hide Arm/Group Description

Active 10% FBR containing bioadhesive gel

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

Color/consistency matched placebo (no black raspberry) gel

Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months

Total of all reporting groups
Overall Number of Baseline Participants 23 18 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 18 participants 41 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  73.9%
5
  27.8%
22
  53.7%
>=65 years
6
  26.1%
13
  72.2%
19
  46.3%
[1]
Measure Description: The patients were randomly assigned by computer generated numbers to either the BRB or the placebo gel groups.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 18 participants 41 participants
62.2  (1.8) 57.7  (2.9) 59.9  (2.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 18 participants 41 participants
Female
14
  60.9%
9
  50.0%
23
  56.1%
Male
9
  39.1%
9
  50.0%
18
  43.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 18 participants 41 participants
23 18 41
1.Primary Outcome
Title Light Microscopic Histologically Scored Diagnoses Pretreatment to Post Treatment
Hide Description 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).
Time Frame Before and after the 3 month treatment.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The population evaluated were as previously described i.e. 22 participants in the BRB gel cohort and 18 participants in the placebo gel cohort.
Arm/Group Title 10% FBR Gel Placebo Gel
Hide Arm/Group Description:

Active 10% FBR containing bioadhesive gel

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

Color/consistency matched placebo (no black raspberry) gel

Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months

Overall Number of Participants Analyzed 22 18
Mean (Standard Error)
Unit of Measure: unit on histologic grade scale
Pretreatment 2.36  (0.35) 2.83  (0.34)
Posttreatment 1.9  (0.21) 2.58  (0.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10% FBR Gel
Comments Wilcoxon matched-pairs signed rank test (intrapatient pre versus post treatment scores)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments Statistical analyses reflect percent change intrapatient pre versus post histologic grade scores
Method Wilcoxon matched-pairs signed rank test
Comments We used a 2-tailed Mann Whitney U test to evaluate these data.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Gel
Comments Wilcoxon matched-pairs signed rank test (pre versus post treatment scores)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments Statistical analyses reflect percent change pre versus post histologic grade scores
Method Wilcoxon matched-pairs signed rank test
Comments [Not Specified]
2.Secondary Outcome
Title Changes in Lesional Sizes
Hide Description 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.
Time Frame pretreatment and posttreatment (3 months treatment duration)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 10% FBR Gel Placebo Gel
Hide Arm/Group Description:

Active 10% FBR containing bioadhesive gel

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.

Color/consistency matched placebo (no black raspberry) gel

Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months

Overall Number of Participants Analyzed 22 18
Mean (Standard Deviation)
Unit of Measure: mm^2
-26.12  (5.81) 18.12  (4.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10% FBR Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.002
Comments [Not Specified]
Method Wilcoxon matched-pairs signed rank test
Comments specifically, we used the Wilcoxon matched-pairs signed rank test.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method Wilcoxon matched-pairs signed rank test
Comments [Not Specified]
3.Secondary Outcome
Title Treatment Changes in Loss of Heterozygosity Events
Hide Description 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.
Time Frame Before and after the 3 month treatment duration
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 10% FBR Gel Placebo Gel
Hide Arm/Group Description:

Active 10% FBR containing bioadhesive gel

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

Color/consistency matched placebo (no black raspberry) gel

Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months

Overall Number of Participants Analyzed 22 18
Mean (Standard Error)
Unit of Measure: LOH events
0.9  (0.02) 0.4  (0.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 10% FBR Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method 2-tailed unpaired t test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo Gel
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method two-tailed unpaired t test
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 10% FBR Gel Placebo Gel
Hide Arm/Group Description

Active 10% FBR containing bioadhesive gel

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

No adverse events

Color/consistency matched placebo (no black raspberry) gel

Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months

No adverse events

All-Cause Mortality
10% FBR Gel Placebo Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
10% FBR Gel Placebo Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
10% FBR Gel Placebo Gel
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/18 (0.00%) 
While we initially planned to include microvascular densities and COX-2 analyses, there were insufficient tissue samples to collect these data. Therefore as we do not have these data we can not report them.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Susan R, Mallery DDS, PhD
Organization: The Ohio State University
Phone: 614 292-5892
Other Publications:
Responsible Party: Susan Mallery DDS, PhD, Ohio State University
ClinicalTrials.gov Identifier: NCT01192204     History of Changes
Other Study ID Numbers: 2009C0086
RC2CA148099 ( U.S. NIH Grant/Contract )
First Submitted: August 30, 2010
First Posted: August 31, 2010
Results First Submitted: April 29, 2015
Results First Posted: August 14, 2015
Last Update Posted: August 14, 2015