Clinical characteristics and pharmacokinetics of purified soy isoflavones: multiple-dose administration to men with prostate neoplasia
| Autor: | Leslie M. Fischer, Steven H. Zeisel, James A. Crowell, John L. Valentine, Thomas E Stinchcombe, Matthew A. Koch, Jarol Boan, A. Robert Jeffcoat, Brian F. Thomas, Chrysa Mahoney |
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| Rok vydání: | 2004 |
| Předmět: |
Male
Cancer Research medicine.medical_specialty Medicine (miscellaneous) Genistein Physiology Phases of clinical research Administration Oral Phytoestrogens Adenocarcinoma chemistry.chemical_compound Prostate cancer Pharmacokinetics Prostate Internal medicine medicine Humans Aged Aged 80 and over Nutrition and Dietetics Dose-Response Relationship Drug business.industry Daidzein food and beverages Cancer Prostatic Neoplasms Isoflavones Middle Aged medicine.disease Antineoplastic Agents Phytogenic medicine.anatomical_structure Endocrinology Treatment Outcome Oncology chemistry Soybeans Safety business Half-Life |
| Zdroj: | Nutrition and cancer. 48(2) |
| ISSN: | 0163-5581 |
| Popis: | A phase I clinical trial was conducted to determine the safety, pharmacokinetic parameters, and efficacy of orally administered isoflavones (genistein and daidzein, potential cancer chemotherapeutic agents) over a 3-mo period in men with prostate neoplasia. Twenty men, ages 40 and above, with stage B, C, or D adenocarcinoma of the prostate were treated with a multiple-dose regimen of a soy isoflavone formulation (delivering approximately 300 or 600 mg/day genistein and half this much daidzein) for 84 days. The delivered dose of isoflavones was more than 10-fold higher than that typically taken by prostate cancer patients. In men with prostate cancer, relatively minor side effects of chronic isoflavone treatment were observed including some estrogenic effects (breast changes, increased frequency of hot flashes). Serum dehydroepiandrosterone was decreased by 31.7% (P = 0.0004) at the end of treatment. Except for those subjects whose prostate-specific antigen (PSA) values were below 0.4 ng/ml, subjects had a history of increasing PSA levels prior to the trial. This increase continued during the trial both while on soy isoflavones and after treatment was discontinued. On average the rate of rise accelerated after soy isoflavones were discontinued, but that difference did not attain statistical significance. Genistein and daidzein were rapidly cleared from plasma and excreted in urine. Pharmacokinetic data for chronic dose administration were similar to single-dose administration for the isoflavones investigated except that we observed slightly longer circulation time for daidzein. |
| Databáze: | OpenAIRE |
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