Bowman-Birk Inhibitor Concentrate in Healthy Men
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy, no Evidence of Disease
In brief
This randomized phase I trial is studying the side effects and best dose of Bowman-Birk inhibitor concentrate in healthy men. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Bowman-Birk inhibitor concentrate may prevent cancer.
Key facts
- Study ID
- NCT00679094
- Run by
- National Cancer Institute (NCI)
- People needed
- 20
- Starts
- 2007-06-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2016-12-29
Who can join
Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- Healthy male participant recruited from the Philadelphia, Pennsylvania metropolitan area
- ECOG performance status 0-2
- WBC ≥ 3,000/uL
- Differential (i.e., neutrophils, lymphocytes, monocytes, bands, eosinophils, and basophils) normal
- Platelet count normal
- Hemoglobin normal
- Hematocrit normal
- RBC normal
- Creatinine normal
- Bilirubin normal
- ALT and AST normal
- Amylase and lipase normal
- Glucose normal
- Cholesterol normal
- Triglycerides normal
- Non-smoker
- Former smokers are eligible provided they have not smoked within the past 3 months
- Within 15% of ideal body weight based on standard weight tables
- No vegetarians or individuals who normally ingest large amounts of soy products, defined as two or more servings of tofu, soy milk, or other primarily soy-based food per day
- No prior allergy or adverse reaction to soybeans
- No diagnosis of cancer within the past 5 years except nonmelanoma skin cancer
- No prior diagnosis of pancreatitis, pancreatic carcinoma, pancreatic adenoma, diabetes mellitus, obstruction of pancreatic ducts, or amyloidosis
- No history of heart disease
- EKG normal (normal variants allowed)
- No evidence of psychiatric problems
Where it is running
- Abramson Cancer Center of The University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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