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| ID | Type | Description | Link |
|---|---|---|---|
| VU-VICC-URO-0369 | |||
| VU-VICC-041001 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Eating a diet high in vegetables may lower the risk of some types of cancer. Brassica vegetables (such as cabbages, kale, broccoli, Brussels sprouts, and cauliflower) and indole-3-carbinol (a substance found in cruciferous vegetables) may help lower the risk of prostate cancer recurrence.
PURPOSE: This randomized clinical trial is studying the side effects and how well Brassica vegetables work compared with indole-3-carbinol in treating patients with PSA recurrence after surgery for prostate cancer.
OBJECTIVES:
OUTLINE: Patients are stratified by pretreatment prostat-specific antigen (PSA) growth rate (low [0.00-0.15] vs medium [0.16-0.30] vs high [> 0.30]). They are randomized to 1 of 3 treatment arms, and randomization status to arms II and III is double-blinded.
Blood and urine samples (for urinary isothiocyanate levels) are collected at baseline and at 2, 4, and 6 months. Patients complete questionnaires assessing demographics, family cancer history, and health history and measuring changes in medications, lifestyle, adverse events, and health. Medical records are reviewed for prostate cancer-related information, surgical dates, dose and type of radiation, and PSA history.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brassica Vegetables Diet Intervention | Experimental |
| |
| Pill | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| behavioral dietary intervention | Behavioral |
| ||
| Brassica vegetable |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Brassica vegetable intake and indole-3-carbinol supplementation | will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention | |
| Adverse events | will be measured at 2-Months, 4-Months, and 6-Months after Baseline start for the diet intervention | |
| Effects of intervention on prostate-specific antigen | Not noted |
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Inclusion Criteria:
Diagnosis of prostate cancer with PSA recurrence after prostatectomy
Exclusion Criteria:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No other concurrent Brassica vegetable consumption > 1 serving/day
No other concurrent indole-3-carbinol supplements
No endocrine or radiation treatment within past 4 weeks
No other scheduled treatment during study intervention
Concurrent prescription medications during the trial allowed
At least 2 weeks since prior and no concurrent vitamin or herbal supplement use
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| Name | Affiliation | Role |
|---|---|---|
| Jay H. Fowke, PhD, MPH | Vanderbilt-Ingram Cancer Center | Study Chair |
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| Dietary Supplement |
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| indole-3-carbinol | Drug | follow up at 2,4,6 months post baseline. |
|
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| counseling intervention | Other | 2, 4, 6 months post baseline |
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| medical chart review | Other | 2,4,6 months post baseline |
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| questionnaire administration | Other |
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| adjuvant therapy | Procedure |
|
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C016517 | indole-3-carbinol |
| D003376 | Counseling |
| D017024 | Chemotherapy, Adjuvant |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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