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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
41 patients were enrolled in this protocol. 1 patient could not keep the appointments and was referred to his private oral surgeon.

Reporting Groups
  Description
10% FBR Gel

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

Placebo Gel

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


Participant Flow:   Overall Study
    10% FBR Gel   Placebo Gel
STARTED   23   18 
COMPLETED   22   18 
NOT COMPLETED   1   0 
could not keep recall appointments                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
10% FBR Gel

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

Placebo Gel

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 Total of all reporting groups

Baseline Measures
   10% FBR Gel   Placebo Gel   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   18   41 
Age [1] 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   17   5   22 
>=65 years   6   13   19 
[1] The patients were randomly assigned by computer generated numbers to either the BRB or the placebo gel groups.
Age 
[Units: Years]
Mean (Standard Deviation)
 62.2  (1.8)   57.7  (2.9)   59.9  (2.4) 
Gender 
[Units: Participants]
     
Female   14   9   23 
Male   9   9   18 
Region of Enrollment 
[Units: Participants]
     
United States   23   18   41 


  Outcome Measures

1.  Primary:   Light Microscopic Histologically Scored Diagnoses Pretreatment to Post Treatment   [ Time Frame: Before and after the 3 month treatment. ]

2.  Secondary:   Changes in Lesional Sizes   [ Time Frame: pretreatment and posttreatment (3 months treatment duration) ]

3.  Secondary:   Treatment Changes in Loss of Heterozygosity Events   [ Time Frame: Before and after the 3 month treatment duration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: mallery.1@osu.edu


Publications of Results:
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