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| ID | Type | Description | Link |
|---|---|---|---|
| 98-34 | |||
| U01CA072294 | U.S. NIH Grant/Contract | View source |
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This randomized phase II trial is studying how well Bowman-Birk inhibitor concentrate works in preventing cancer in patients with oral leukoplakia. Chemoprevention is the use of certain substances to keep cancer from forming, growing, or coming back. The use of Bowman-Birk inhibitor concentrate, a substance made from soy, may keep cancer from forming in patients with oral leukoplakia
PRIMARY OBJECTIVES:
I. Determine if chemoprevention by the Bowman-Birk inhibitor concentrate (BBIC) can prevent cancer in patients with oral leukoplakia (OL).
II. Determine the clinical and histologic response rate of OL to BBIC.
SECONDARY OBJECTIVES:
I. Measure the effect of BBIC on intermediate marker endpoint levels. II. Correlate the clinical and histologic responses of OL with cellular levels of proteolytic activity, erb-B2 (neu), retinioc acid receptor β, bcl-2, and mutant p53 expression, and serum levels of neu.
III. Determine the individual and group side effects of BBIC.
OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled, study. Prior to randomization, all patients receive oral placebo for 4 weeks. Patients who show good compliance (> 75% packet count) are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive oral placebo twice daily for 6 months in the absence of disease progression or unacceptable toxicity.
Patients complete questionnaires about diet, tobacco, and alcohol usage at baseline and at the completion of study treatment. Blood, urine, and biopsy tissue are collected at baseline and at the completion of study treatment. Oral mucosal cells are collected at baseline, during the run-in phase, at randomization, after completion of study treatment, and at 3 months after completion of study treatment. Samples are examined for protease activity, levels of bcl-2 and erbB-2, mutant p53 oncogene expression and epidermal growth factor receptor, and retinoic acid receptor-β expression.
After completion of study treatment, patients are followed at 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Bowman-Birk inhibitor concentrate) | Experimental | Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months |
|
| Arm II (placebo) | Placebo Comparator | Patients receive oral placebo twice daily for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bowman-Birk inhibitor concentrate | Drug | Given orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative Percent Change in Total Lesion Area After 6 Months on Study | Relative percent change in total lesion area was defined as 100 times (area posttreatment minus area pretreatment) all divided by pretreatment area. | 6 months |
| Number of Participants by Category of Clinical Response at 6 Months | Category of clinical response was based on the magnitude of relative percent change in total lesion area. A complete response (CR) was declared if the relative percent change in total lesion area was minus 100 percent. A partial response (PR) was a relative percent decrease in total lesion area of 50% or more, without being a CR. Disease progression was a relative percent increase in total lesion area of at least 50%. Remaining cases were declared to be stable disease. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen | The reviewer was blinded to study-arm assignment (drug or placebo), but not to time point of specimen. For each specimen, the reviewer marked a continuum to indicate degree of tissue abnormality. The continuum was 140 mm long, and anchored by the word 'Normal' on the left and 'Malignant' on the right. The distance from the left edge of the continuum to the reviewer's mark, in mm, was determined. For analyses, a score was formed by subtracting the pretreatment value from the 6-month value. Thus, a retreat from 'Malignancy' over time produces a negative score, a score of zero denotes no change, and a positive score denotes a worsening situation. Positive values indicate histologic worsening, whereas negative scores denote improvement over the 6-month study period. |
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Inclusion Criteria:
Histologically and clinically confirmed oral leukoplakia and/or erythroplakia
Bidimensionally measurable disease (≥ 100 mm^2 for total area of all lesions) after biopsy
No presence of obvious head and neck aerodigestive tract cancer, carcinoma in situ, or previously treated head and neck cancer within the past 2 years
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No history of allergic reaction to soybeans, sorbitol, sucrose, artificial flavorings, aspartame, saccharin, or lidocaine
At least 6 months since prior Bowman-Birk inhibitor concentrate
At least 6 months since prior participation in another randomized clinical trail
At least 3 months since prior systemic steroids or topical oral steroid preparations
More than 6 months since prior beta carotene capsules
At least 2 years since prior retinoid or other beta carotene therapy, including > 25,000 IU of vitamin A for any reason
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| Name | Affiliation | Role |
|---|---|---|
| Frank Meyskens | University of California Medical Center At Irvine-Orange Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Medical Center At Irvine-Orange Campus | Orange | California | 92868 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11795430 | Background | Meyskens FL. Development of Bowman-Birk inhibitor for chemoprevention of oral head and neck cancer. Ann N Y Acad Sci. 2001 Dec;952:116-23. doi: 10.1111/j.1749-6632.2001.tb02732.x. | |
| 11220668 | Background | Meyskens FL Jr. Development of difluoromethyl-ornithine and Bowman-Birk inhibitor as chemopreventive agents by assessment of relevant biomarker modulation: some lessons learned. IARC Sci Publ. 2001;154:49-55. |
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Of 325 consented, 157 (48%) completed the run-in period but 25 declined to continue, resulting in 132 randomized patients.
A total of 513 people were screened for participation across all 8 performance sites, of which 188 (37%) were ineligible and 325 were consented.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Arm II (Placebo) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Other | Given orally |
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| laboratory biomarker analysis | Other | Correlative studies |
|
| Baselie to 6 months |
| Clinical Impression From Photographs | A secondary clinical response measure was bsaed on blinded, comparative judgments of pairs of photographs of the same lesion at baseline and 6 months on study. Picture pairs were assigned to album page, one pair per page, at random. Five physicians experienced with evaluation of oral mucosal tissue abnormalities, but blinded to study arm and time point, independently compared the pictures in each pair using a 7-point scale. The scale ranged from, "top photo shows a complete response relative to the bottom photo," through, "the same degree of disease is shown by top photo and bottom photo," to "bottom photo shows a complete response relative to the top photo." Raw scores were transformed to account for relative position of the earlier and later photo, and averaged across the 5 reviewers. Final scores ranged from one, denoting a CR at 6 months, to 4, which indicated no change, through 7, which indicated that the 6-month photo depicted a much worse situation than the pretreatment photo. | Baseline to 6 months |
| Relative Percent Change in Buccal-Cell Neu Protein (ng/mg) | 100% x (Posttreatment value - pretreatment value)/(pretreatment value) | Baseline to 6 months |
| Relative Percent Change in Serum Neu Protein (ng/ml) | 100% x (Posttreatment value - pretreatment value)/(pretreatment value) | Baseline to 6 months |
| Relative Percent Change in Protease Activity (Delta RFU/Min/µg) | 100% x (Posttreatment value - pretreatment value)/(pretreatment value) | Baseline to 6 months |
| Number of Participants Report at Least 1 Adverse Event During the Study | The onset of adverse event is between the randomizaiton date and off-study date | Randomized date to Off-study date, up to 21 months |
| Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months | Baseline to 6 months |
| 23639862 | Result | Armstrong WB, Taylor TH, Kennedy AR, Melrose RJ, Messadi DV, Gu M, Le AD, Perloff M, Civantos F, Goodwin WJ, Wirth LJ, Kerr AR, Meyskens FL Jr. Bowman birk inhibitor concentrate and oral leukoplakia: a randomized phase IIb trial. Cancer Prev Res (Phila). 2013 May;6(5):410-8. doi: 10.1158/1940-6207.CAPR-13-0004. |
| 14520092 | Result | Armstrong WB, Wan XS, Kennedy AR, Taylor TH, Meyskens FL Jr. Development of the Bowman-Birk inhibitor for oral cancer chemoprevention and analysis of Neu immunohistochemical staining intensity with Bowman-Birk inhibitor concentrate treatment. Laryngoscope. 2003 Oct;113(10):1687-702. doi: 10.1097/00005537-200310000-00007. |
Patients receive oral placebo twice daily for 6 months placebo: Given orally laboratory biomarker analysis: Correlative studies |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Arm II (Placebo) | Patients receive oral placebo twice daily for 6 months placebo: Given orally laboratory biomarker analysis: Correlative studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relative Percent Change in Total Lesion Area After 6 Months on Study | Relative percent change in total lesion area was defined as 100 times (area posttreatment minus area pretreatment) all divided by pretreatment area. | The participants who have complete data are analyzed in this outcome measure. | Posted | Mean | Standard Deviation | percentage change | 6 months |
|
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| ||||||||||||||||||||||||||||
| Secondary | The Difference in Rated Degree of Malignancy Between Randomization and 6-month Specimen | The reviewer was blinded to study-arm assignment (drug or placebo), but not to time point of specimen. For each specimen, the reviewer marked a continuum to indicate degree of tissue abnormality. The continuum was 140 mm long, and anchored by the word 'Normal' on the left and 'Malignant' on the right. The distance from the left edge of the continuum to the reviewer's mark, in mm, was determined. For analyses, a score was formed by subtracting the pretreatment value from the 6-month value. Thus, a retreat from 'Malignancy' over time produces a negative score, a score of zero denotes no change, and a positive score denotes a worsening situation. Positive values indicate histologic worsening, whereas negative scores denote improvement over the 6-month study period. | The participants who have complete data are analyzed in this outcome measure. | Posted | Mean | Standard Deviation | score | Baselie to 6 months |
| ||||||||||||||||||||||||||||||
| Primary | Number of Participants by Category of Clinical Response at 6 Months | Category of clinical response was based on the magnitude of relative percent change in total lesion area. A complete response (CR) was declared if the relative percent change in total lesion area was minus 100 percent. A partial response (PR) was a relative percent decrease in total lesion area of 50% or more, without being a CR. Disease progression was a relative percent increase in total lesion area of at least 50%. Remaining cases were declared to be stable disease. | The participants who have complete data are analyzed in this outcome measure. | Posted | Number | participants | 6 months |
|
| ||||||||||||||||||||||||||||||
| Secondary | Clinical Impression From Photographs | A secondary clinical response measure was bsaed on blinded, comparative judgments of pairs of photographs of the same lesion at baseline and 6 months on study. Picture pairs were assigned to album page, one pair per page, at random. Five physicians experienced with evaluation of oral mucosal tissue abnormalities, but blinded to study arm and time point, independently compared the pictures in each pair using a 7-point scale. The scale ranged from, "top photo shows a complete response relative to the bottom photo," through, "the same degree of disease is shown by top photo and bottom photo," to "bottom photo shows a complete response relative to the top photo." Raw scores were transformed to account for relative position of the earlier and later photo, and averaged across the 5 reviewers. Final scores ranged from one, denoting a CR at 6 months, to 4, which indicated no change, through 7, which indicated that the 6-month photo depicted a much worse situation than the pretreatment photo. | The participants who have complete data are analyzed in this outcome measure. | Posted | Mean | Standard Deviation | score | Baseline to 6 months |
| ||||||||||||||||||||||||||||||
| Secondary | Relative Percent Change in Buccal-Cell Neu Protein (ng/mg) | 100% x (Posttreatment value - pretreatment value)/(pretreatment value) | The participants who have complete data are analyzed in this outcome measure. | Posted | Median | 95% Confidence Interval | percentage change | Baseline to 6 months |
|
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| Secondary | Relative Percent Change in Serum Neu Protein (ng/ml) | 100% x (Posttreatment value - pretreatment value)/(pretreatment value) | The participants who have complete data are analyzed in this outcome measure. | Posted | Median | 95% Confidence Interval | percentage change | Baseline to 6 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Relative Percent Change in Protease Activity (Delta RFU/Min/µg) | 100% x (Posttreatment value - pretreatment value)/(pretreatment value) | The participants who have complete data are analyzed in this outcome measure. | Posted | Median | 95% Confidence Interval | percentage change | Baseline to 6 months |
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| Secondary | Number of Participants Report at Least 1 Adverse Event During the Study | The onset of adverse event is between the randomizaiton date and off-study date | Posted | Number | participants | Randomized date to Off-study date, up to 21 months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Combined Percentage Change From Baseline in Proteolytic Activity, Buccal-cell Erb-B2 (Neu) and Serum Levels of Neu at 6 Months | The participants whose data are available and complete are included in the analysis. | Posted | Median | 95% Confidence Interval | percentage change | Baseline to 6 months |
|
|
The adverse-event reports were dated on or after randomization, up to 21 months.
The number of adverse-event reports from the 132 randomized subjects dated on or after randomization was 138.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 5 | 67 | 30 | 67 | ||
| EG001 | Arm II (Placebo) | Patients receive oral placebo twice daily for 6 months placebo: Given orally laboratory biomarker analysis: Correlative studies | 0 | 65 | 25 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ADMISSION FOR ORAL SURGERY ON FLOOR MOUTH | Surgical and medical procedures | Non-systematic Assessment |
| ||
| C/O "LUMP" TO RT. LOWER GUM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| COLD | General disorders | Non-systematic Assessment |
| ||
| EPIGASTRIC PAIN | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| FINGER INFECTION - LEFT RING | Infections and infestations | Non-systematic Assessment |
| ||
| HEART PROBLEMS | Cardiac disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 6 CROWNS | Surgical and medical procedures | Non-systematic Assessment |
| ||
| ABD PN AND BLOATING | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| ABDOMINAL PAIN | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| BACK PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| BAD BREATH | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| BAD CANKER LOWER LIP | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| BAD COLD | General disorders | Non-systematic Assessment |
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| BLEEDING HEMORRHOIDS | Gastrointestinal disorders | Non-systematic Assessment |
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| BLOATED | Gastrointestinal disorders | Non-systematic Assessment |
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| BRONCHITIS | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| BRONCHITIS/FLU | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| CAD | Cardiac disorders | Non-systematic Assessment |
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| CANKER SORES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| CARDIAC STENT | Cardiac disorders | Non-systematic Assessment |
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| CARDIOVASCULAR OTHER - GENERAL | Cardiac disorders | Non-systematic Assessment |
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| CELLULITIS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| CHEST PAIN | Cardiac disorders | Non-systematic Assessment |
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| CHIP FX ON RIGHT BIG TOE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| COLD | General disorders | Non-systematic Assessment |
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| COLD SORES | Infections and infestations | Non-systematic Assessment |
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| COMPLAINED OF TASTE | Nervous system disorders | Non-systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | Non-systematic Assessment |
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| CUT HAND WHILE PLAYING SOCCER AND NEEDED STITCHES | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| DECREASED SEXUAL APPETITE | Psychiatric disorders | Non-systematic Assessment |
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| DENTAL IMPLANTS | Gastrointestinal disorders | Non-systematic Assessment |
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| DIARRHEA | Gastrointestinal disorders | Non-systematic Assessment |
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| DIDN'T LIKE TASTE AFTER RUN IN AND THEN RANDOMIZED, STATED THAT HE "DIDN'T FEEL IT WAS WORKING". | Nervous system disorders | Non-systematic Assessment |
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| DRY LIPS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| DRY MOUTH | Gastrointestinal disorders | Non-systematic Assessment |
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| EAR INFECTION/IRREGULAR BUMP | Ear and labyrinth disorders | Non-systematic Assessment |
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| EPIGASTRIC PAIN | Gastrointestinal disorders | Non-systematic Assessment |
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| EPIGASTRIC PAIN AND NAUSEA | Gastrointestinal disorders | Non-systematic Assessment |
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| FALL, COMPRESSION OF T11-L1 VERTEBRAL BODY | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| FISSURE FX | Gastrointestinal disorders | Non-systematic Assessment |
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| FLU X 1 | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| FLU X 2 | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| FLU X 6 D | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| FLU/COLD | General disorders | Non-systematic Assessment |
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| FNA AND BIOPSY OF MASS INTRAMUSCULAR LIPOMA | Surgical and medical procedures | Non-systematic Assessment |
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| GAS-BUT THIS HAS DISAPPEARED AFTER BEING ON POWDER FOR ONE WEEK. | Gastrointestinal disorders | Non-systematic Assessment |
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| GUM BLEEDING | Gastrointestinal disorders | Non-systematic Assessment |
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| GUM EROSION (SONIC TOOTHBRUSH) | Gastrointestinal disorders | Non-systematic Assessment |
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| GUMS FEEL SORE/TENDER | Gastrointestinal disorders | Non-systematic Assessment |
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| HANDS NUMB | Nervous system disorders | Non-systematic Assessment |
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| HEAD COLD | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| HEADACHE | Nervous system disorders | Non-systematic Assessment |
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| HEADACHES | Nervous system disorders | Non-systematic Assessment |
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| HIVES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| HOSPITALIZAED RIGHT KNEE REPLACEMENT | Surgical and medical procedures | Non-systematic Assessment |
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| INCREASED HAIR LOSS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| INCREASED SENSITIVITY WITH SPICY FOOD, IE FROM MED TO MILD SALSA | Gastrointestinal disorders | Non-systematic Assessment |
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| INCREASED TONGUE PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| ITCHY FOREARM, POSSIBLE BUG BITE REACTION | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| KIDNEY STONES | Renal and urinary disorders | Non-systematic Assessment |
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| LOOSE STOOLS | Gastrointestinal disorders | Non-systematic Assessment |
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| LOWER LEFT JAW LESION FEELS ODD/STRETCHY | Psychiatric disorders | Non-systematic Assessment |
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| LT. FOOT RUPTURED TENDON | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| LT. FOOT THROMBUS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| LT. FOOT THROMBUS CONTINUES | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| MASS 2-3 CM ON CT OF ABDOMEN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| MOUTH SORES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | Non-systematic Assessment |
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| NAUSEA/ABD CRAMPING | Gastrointestinal disorders | Non-systematic Assessment |
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| NEW SPOTS IN THROAT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| ORAL SORENESS | General disorders | Non-systematic Assessment |
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| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| POISON OAK | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| PT FELL. LEFT EYEBROW AREA BRUISED | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| REDNESS OUTER ASPECT LIPS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| ROOF OF MOUTH MORE SENSITIVE | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| RT HAND LITTLE FINGER BROKEN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| SCIATIC LEG PAIN | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| SCIATICA | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| SHINGLES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| SINUS INFECTION, TOOK ZITHROMAX | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| SOFT STOOL | Gastrointestinal disorders | Non-systematic Assessment |
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| SORE - TONGUE | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| SORE MOUTH | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| SORE MOUTH - CORNERS AND GUMS | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| SORE THROAT | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| SORE TONGUE BOTH SIDES | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| STOMACH ACHE | Gastrointestinal disorders | Non-systematic Assessment |
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| STOMACH DISTRESS WITH SPICY FOODS | Gastrointestinal disorders | Non-systematic Assessment |
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| STOMACH FLU | Gastrointestinal disorders | Non-systematic Assessment |
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| STOMACH PAIN | Gastrointestinal disorders | Non-systematic Assessment |
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| SURGERY ON FINGER | Surgical and medical procedures | Non-systematic Assessment |
| ||
| TASTED LIKE YEAST | Nervous system disorders | Non-systematic Assessment |
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| TASTES BAD | Nervous system disorders | Non-systematic Assessment |
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| THINNING HAIR | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| THROAT DRY AND CHAULKY | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| TIRED AND DIDN'T FEEL LIKE TAKING | Psychiatric disorders | Non-systematic Assessment |
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| TIRED. IN RETROSPECT FELT TIRED DUE TO WORK. | General disorders | Non-systematic Assessment |
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| TONGUE NUMBNESS COMES AND GOES | Nervous system disorders | Non-systematic Assessment |
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| TONGUE NUMBNESS, TINGLING AND DRY MOUTH | Nervous system disorders | Non-systematic Assessment |
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| TOOTH EXTRACTION | Gastrointestinal disorders | Non-systematic Assessment |
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| TOOTH INFECTION | Gastrointestinal disorders | Non-systematic Assessment |
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| TOOTH PULLED/EAR PAIN/ TOOTH DECAY | Gastrointestinal disorders | Non-systematic Assessment |
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| TOUNGE PAIN CONTINUES | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| TOUNGE SORENESS | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| ULCERATION (SMALL) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| ULCERATION X3 | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| UNDERGOING ROOT CANAL | Surgical and medical procedures | Non-systematic Assessment |
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| UPPER RESPIRATORY INFECTION AND SORE THROAT | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| UPSET STOMACH | Gastrointestinal disorders | Non-systematic Assessment |
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| UPSET STOMACH AND GAS | Gastrointestinal disorders | Non-systematic Assessment |
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| URINARY FREQUENCY | Renal and urinary disorders | Non-systematic Assessment |
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| VOMITING - 2X THEN STOPPED | Gastrointestinal disorders | Non-systematic Assessment |
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| WEIGHT LOSS 10LB DUE TO PAIN | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| YEAST INFECTION | Infections and infestations | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frank Meyskens, Jr. | University of California, Irvine | 714-456-6310 | flmeyske@uci.edu |
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D007972 | Leukoplakia, Oral |
| D009959 | Oropharyngeal Neoplasms |
| D014062 | Tongue Neoplasms |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007971 | Leukoplakia |
| D011230 | Precancerous Conditions |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014060 | Tongue Diseases |
Not provided
Not provided
| Male |
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Patients receive oral placebo twice daily for 6 months
placebo: Given orally
laboratory biomarker analysis: Correlative studies
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