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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-02387 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R21CA125909 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Eating a diet high in soy foods may lower the risk of some types of cancer. Isoflavones are compounds found in soy food that may prevent cancer.
PURPOSE: This randomized phase II trial is studying how well soy isoflavones work in treating patients with recurrent prostate cancer or rising prostate-specific antigen
OBJECTIVES:
I. To precisely quantify the absorption, serum concentrations over time, and excretion patterns of soy isoflavones and metabolites in men consuming the two bread products to define relationships between dietary intake, isoflavone metabolism and the biological outcomes.
II. To describe the safety as well as incidence and severity of toxicity in men consuming the control soy bread or beta-glucosidase-enriched soy bread.
III. To see if consumption of beta-glucosidase-enriched soy bread compared to control soy bread has a greater effect on blood hormonal patterns and biomarkers that favor anti-prostate cancer activity.
IV. To see if beta-glucosidase-enriched soy bread compared to control soy bread improves hormonal patterns (lower insulin like growth factor-I, increased insulin like growth factor binding protein 3, lower androgens), reduce prostate specific antigen velocity, and lower circulating vascular endothelial growth factor concentrations.
OUTLINE: Patients are randomized to 1 of 2 treatment arms (closed to accrual as of 02/14/2011).
ARM I: Patients consume 2 slices of soy bread daily for 8 weeks.
ARM II: Patients consume 2 slices of soy almond bread daily for 8 weeks.
After a 2 week washout period, patients crossover to the alternate treatment arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Soy Bread Intervention | Active Comparator | Arm I Soy Bread |
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| Soy -Almond Bread Intervention | Experimental | Arm II Soy-Almond Bread |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm I Soy Bread | Dietary Supplement | On day 0 or day 70 pharmacokinetic study of isoflavones over 24 hours will follow after consumption of 2 slices of soy bread. Afterwards 2 slices of soy bread/day will be consumed for 56 days and isoflavone metabolites will be assessed in urine at days 0, 28, 56, 70, 98, and 126. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentrations (Cmax) of soy isoflavones and their metabolites | Quantification of absorption, serum concentrations over time, and excretion patterns of soy isoflavones and metabolites to define relationships between dietary intake, isoflavone metabolism and the biological outcomes | 0, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change in hormonal patterns after soy bread and soy-almond bread interventions | Comparison of hormonal patterns (lower insulin like growth factor-I, increased insulin like growth factor binding protein-3, lower androgens), prostate specific antigen velocity, and circulating vascular endothelial growth factor concentrations | Day 0, 56, 70, and126 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yael Vodovotz | Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| Jamesline | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D030262 | Soybean Proteins |
| ID | Term |
|---|---|
| D010940 | Plant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014674 | Plant Proteins, Dietary |
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| Arm II Soy-Almond Bread | Dietary Supplement | On day 0 or day 70 pharmacokinetic study of isoflavones over 24 hours will follow after consumption of 2 slices of soy-almond bread. Afterwards 2 slices of soy-almond bread/day will be consumed for 56 days and isoflavone metabolites will be assessed in urine at days 0, 28, 56, 70, 98, and 126. |
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| Changes in hormonal patterns that favor anti-prostate cancer activity | Comparison of isoflavone metabolites on blood hormonal patterns and biomarkers that favor anti-prostate cancer activity. | Days 0, 28, 56, 70, 98, and 126 |
| Severity of toxicity in participants after consumption of the control soy bread or beta-glucosidase-enriched soy almond bread | Safety (NIH criteria) and toxicity will be measured at day 0 (start of first intervention), day 56 (end of first intervention), day 70 (start of second intervention), and day 126 (end of second intervention) | Day 0 and Day 126 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D004044 |
| Dietary Proteins |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D045730 | Soy Foods |
| D000067075 | Vegetable Products |
| D014675 | Vegetables |
| D019602 | Food and Beverages |