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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Time Frame The adverse-event reports were dated on or after randomization, up to 21 months.
Additional Description The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

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


Other Adverse Events
    Arm I (Bowman-Birk Inhibitor Concentrate)   Arm II (Placebo)
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   30/67 (44.78%)   25/65 (38.46%) 
Cardiac disorders     
CAD     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
CARDIAC STENT     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
CARDIOVASCULAR OTHER - GENERAL     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   2   0 
CHEST PAIN     
# participants affected / at risk   0/67 (0.00%)   2/65 (3.08%) 
# events   0   2 
Ear and labyrinth disorders     
EAR INFECTION/IRREGULAR BUMP     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
Gastrointestinal disorders     
ABD PN AND BLOATING     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
ABDOMINAL PAIN     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
BAD BREATH     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
BLEEDING HEMORRHOIDS     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
BLOATED     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
CONSTIPATION     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
DENTAL IMPLANTS     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
DIARRHEA     
# participants affected / at risk   3/67 (4.48%)   1/65 (1.54%) 
# events   4   1 
DRY MOUTH     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
EPIGASTRIC PAIN     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
EPIGASTRIC PAIN AND NAUSEA     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
FISSURE FX     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
GAS-BUT THIS HAS DISAPPEARED AFTER BEING ON POWDER FOR ONE WEEK.     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
GUM BLEEDING     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   2 
GUM EROSION (SONIC TOOTHBRUSH)     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
GUMS FEEL SORE/TENDER     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
INCREASED SENSITIVITY WITH SPICY FOOD, IE FROM MED TO MILD SALSA     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
LOOSE STOOLS     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
NAUSEA     
# participants affected / at risk   2/67 (2.99%)   0/65 (0.00%) 
# events   2   0 
NAUSEA/ABD CRAMPING     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
SOFT STOOL     
# participants affected / at risk   2/67 (2.99%)   0/65 (0.00%) 
# events   2   0 
STOMACH ACHE     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
STOMACH DISTRESS WITH SPICY FOODS     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
STOMACH FLU     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
STOMACH PAIN     
# participants affected / at risk   1/67 (1.49%)   1/65 (1.54%) 
# events   1   1 
TOOTH EXTRACTION     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
TOOTH INFECTION     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
TOOTH PULLED/EAR PAIN/ TOOTH DECAY     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
UPSET STOMACH     
# participants affected / at risk   1/67 (1.49%)   1/65 (1.54%) 
# events   1   1 
UPSET STOMACH AND GAS     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
VOMITING - 2X THEN STOPPED     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
General disorders     
BAD COLD     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
COLD     
# participants affected / at risk   3/67 (4.48%)   1/65 (1.54%) 
# events   3   1 
FLU/COLD     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
ORAL SORENESS     
# participants affected / at risk   2/67 (2.99%)   0/65 (0.00%) 
# events   3   0 
TIRED. IN RETROSPECT FELT TIRED DUE TO WORK.     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
Infections and infestations     
COLD SORES     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
YEAST INFECTION     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
Injury, poisoning and procedural complications     
CUT HAND WHILE PLAYING SOCCER AND NEEDED STITCHES     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
FALL, COMPRESSION OF T11-L1 VERTEBRAL BODY     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
PT FELL. LEFT EYEBROW AREA BRUISED     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
Metabolism and nutrition disorders     
WEIGHT LOSS 10LB DUE TO PAIN     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
Musculoskeletal and connective tissue disorders     
BACK PAIN     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
CHIP FX ON RIGHT BIG TOE     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
INCREASED TONGUE PAIN     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
LT. FOOT RUPTURED TENDON     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
LT. FOOT THROMBUS     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
LT. FOOT THROMBUS CONTINUES     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   3 
RT HAND LITTLE FINGER BROKEN     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
SCIATIC LEG PAIN     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
SCIATICA     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
SORE - TONGUE     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
SORE TONGUE BOTH SIDES     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
TOUNGE PAIN CONTINUES     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
TOUNGE SORENESS     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
MASS 2-3 CM ON CT OF ABDOMEN     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
NEW SPOTS IN THROAT     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
Nervous system disorders     
COMPLAINED OF TASTE     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
DIDN'T LIKE TASTE AFTER RUN IN AND THEN RANDOMIZED, STATED THAT HE "DIDN'T FEEL IT WAS WORKING".     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
HANDS NUMB     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
HEADACHE     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
HEADACHES     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
TASTED LIKE YEAST     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
TASTES BAD     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
TONGUE NUMBNESS COMES AND GOES     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
TONGUE NUMBNESS, TINGLING AND DRY MOUTH     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
Psychiatric disorders     
DECREASED SEXUAL APPETITE     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
LOWER LEFT JAW LESION FEELS ODD/STRETCHY     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
TIRED AND DIDN'T FEEL LIKE TAKING     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
Renal and urinary disorders     
KIDNEY STONES     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   2   0 
URINARY FREQUENCY     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
Respiratory, thoracic and mediastinal disorders     
BRONCHITIS     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
BRONCHITIS/FLU     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
FLU X 1     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
FLU X 2     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
FLU X 6 D     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
HEAD COLD     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
PNEUMONIA     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
SINUS INFECTION, TOOK ZITHROMAX     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
SORE THROAT     
# participants affected / at risk   1/67 (1.49%)   1/65 (1.54%) 
# events   1   1 
THROAT DRY AND CHAULKY     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
UPPER RESPIRATORY INFECTION AND SORE THROAT     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
Skin and subcutaneous tissue disorders     
BAD CANKER LOWER LIP     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
CANKER SORES     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
CELLULITIS     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
DRY LIPS     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
HIVES     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
INCREASED HAIR LOSS     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
ITCHY FOREARM, POSSIBLE BUG BITE REACTION     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
MOUTH SORES     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   2 
POISON OAK     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
RASH     
# participants affected / at risk   2/67 (2.99%)   0/65 (0.00%) 
# events   2   0 
REDNESS OUTER ASPECT LIPS     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
ROOF OF MOUTH MORE SENSITIVE     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
SHINGLES     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
SORE MOUTH     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
SORE MOUTH - CORNERS AND GUMS     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
THINNING HAIR     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
ULCERATION (SMALL)     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
ULCERATION X3     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
Surgical and medical procedures     
6 CROWNS     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
FNA AND BIOPSY OF MASS INTRAMUSCULAR LIPOMA     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
HOSPITALIZAED RIGHT KNEE REPLACEMENT     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
SURGERY ON FINGER     
# participants affected / at risk   0/67 (0.00%)   1/65 (1.54%) 
# events   0   1 
UNDERGOING ROOT CANAL     
# participants affected / at risk   1/67 (1.49%)   0/65 (0.00%) 
# events   1   0 
* Events were collected by non-systematic assessment



  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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Frank Meyskens, Jr.
Organization: University of California, Irvine
phone: 714-456-6310
e-mail: flmeyske@uci.edu


Publications of Results:
Other Publications:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00330382     History of Changes
Other Study ID Numbers: NCI-2009-00888
98-34
U01CA072294 ( U.S. NIH Grant/Contract )
First Submitted: May 25, 2006
First Posted: May 26, 2006
Results First Submitted: October 3, 2014
Results First Posted: December 19, 2014
Last Update Posted: December 19, 2014