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Trial record 44 of 2060 for:    Oral Cancer | NIH

Bowman-Birk Inhibitor Concentrate in Preventing Cancer in Patients With Oral Leukoplakia

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ClinicalTrials.gov Identifier: NCT00330382
Recruitment Status : Completed
First Posted : May 26, 2006
Results First Posted : December 19, 2014
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions: Lip and Oral Cavity Cancer
Oral Leukoplakia
Oropharyngeal Cancer
Tongue Cancer
Interventions: Drug: Bowman-Birk inhibitor concentrate
Other: placebo
Other: laboratory biomarker analysis

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 513 people were screened for participation across all 8 performance sites, of which 188 (37%) were ineligible and 325 were consented.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 325 consented, 157 (48%) completed the run-in period but 25 declined to continue, resulting in 132 randomized patients.

Reporting Groups
  Description
Arm I (Bowman-Birk Inhibitor Concentrate)

Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months

Bowman-Birk inhibitor concentrate: Given orally

laboratory biomarker analysis: Correlative studies

Arm II (Placebo)

Patients receive oral placebo twice daily for 6 months

placebo: Given orally

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Arm I (Bowman-Birk Inhibitor Concentrate)   Arm II (Placebo)
STARTED   67   65 
COMPLETED   43   48 
NOT COMPLETED   24   17 



  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
Arm I (Bowman-Birk Inhibitor Concentrate)

Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months

Bowman-Birk inhibitor concentrate: Given orally

laboratory biomarker analysis: Correlative studies

Arm II (Placebo)

Patients receive oral placebo twice daily for 6 months

placebo: Given orally

laboratory biomarker analysis: Correlative studies

Total Total of all reporting groups

Baseline Measures
   Arm I (Bowman-Birk Inhibitor Concentrate)   Arm II (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 67   65   132 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.25  (13.63)   60.64  (12.01)   59.42  (12.87) 
Gender 
[Units: Participants]
     
Female   26   25   51 
Male   41   40   81 


  Outcome Measures

1.  Primary:   Relative Percent Change in Total Lesion Area After 6 Months on Study   [ Time Frame: 6 months ]

2.  Primary:   Number of Participants by Category of Clinical Response at 6 Months   [ Time Frame: 6 months ]

3.  Secondary:   The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen   [ Time Frame: Baselie to 6 months ]

4.  Secondary:   Clinical Impression From Photographs   [ Time Frame: Baseline to 6 months ]

5.  Secondary:   Relative Percent Change in Buccal-Cell Neu Protein (ng/mg)   [ Time Frame: Baseline to 6 months ]

6.  Secondary:   Relative Percent Change in Serum Neu Protein (ng/ml)   [ Time Frame: Baseline to 6 months ]

7.  Secondary:   Relative Percent Change in Protease Activity (Delta RFU/Min/µg)   [ Time Frame: Baseline to 6 months ]

8.  Secondary:   Number of Participants Report at Least 1 Adverse Event During the Study   [ Time Frame: Randomized date to Off-study date, up to 21 months ]

9.  Secondary:   Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months   [ Time Frame: Baseline to 6 months ]


  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
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  More Information