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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00326 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This Phase I/Ib trial is studying the absorption and metabolism of phytochemicals found in black raspberries in men undergoing surgery for prostate cancer. This knowledge will help us design future chemoprevention studies and assist in making future dietary recommendations for men at high risk for prostate cancer.
PRIMARY OBJECTIVES:
I. To conduct a dose-escalation study to determine safety and compliance of varying lyophilized black raspberry (LBR) delivery vehicles (a confection and a nectar) at two different doses.
SECONDARY OBJECTIVES:
I. To precisely quantify changes in the content and distribution of black raspberry phytochemicals and their metabolites in the blood and urine and correlate these concentrations with prostate tissue phytochemicals.
II. Measure the ability of black raspberry gummy confection and nectar in altering hormonal patterns (lower insulin-like growth factor-1 [IGF-I], higher insulin-like growth factor-binding protein 3 [IGF-BP3], lower androgens) consistent with reduced prostate carcinogenesis and in parallel with an enhanced capacity to quench reactive oxygen.
III. Investigate histopathologic, immunologic, and molecular biomarkers associated with prostate carcinogenesis that may serve as surrogate endpoint biomarkers and provide information regarding their ability to be modulated by black raspberries.
IV. Determine if consumption of black raspberries alters molecular markers in the human prostate including: (a) neuroendocrine markers such as IGF-I and IGF-BP3, (b) signal transduction markers such as phosphatase and tensin homologue (PTEN) and phospho-AKT, and (c) angiogenesis regulators such as (vascular epithelial growth factor (VEGF).
V. Collect and store plasma and peripheral blood mononuclear cells (PBMCs) from each patient to assess systemic markers of inflammation and immune response.
OUTLINE: This is a dose-escalation study of lyophilized black raspberry gummy confection and nectar. Patients are assigned to 1 of 7 treatment arms.
ARM I: Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy.
ARM II: Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy.
ARM III: Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy.
ARM IV: Patients follow a low ellagitannin diet and consume a lower-dose black raspberry confection daily for 4-6 weeks and then undergo prostatectomy.
ARM V: Patients follow a low ellagitannin diet and consume a higher-dose black raspberry confection daily for 4-6 weeks and then undergo prostatectomy.
ARM VI: Patients follow a low ellagitannin diet and consume a lower-dose black raspberry nectar daily for 4-6 weeks and then undergo prostatectomy.
ARM VII: Patients follow a low ellagitannin diet and consume a higher-dose black raspberry nectar daily for 4-6 weeks and then undergo prostatectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (regular diet) | Active Comparator | Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy. |
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| Arm II (low polyphenol diet) | Active Comparator | Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy. |
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| Arm III (low ellagitannin diet) | Active Comparator | Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy. |
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| Arm IV (lower-dose lyophilized black raspberry confection) | Experimental | Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection each day for 4-6 weeks and then undergo prostatectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lyophilized black raspberry confection | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Assessed Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Adverse events were measured by asking participants at each study visit about any new symptoms which may or may not be related to the intervention. No adverse events were reported from any subjects. | Up to 30 days after completion of study treatment |
| Percentage of Intervention Consumed | A cohort will be considered compliant if the group mean consumption of the intervention product is at least 80%. | Up to 6-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Black Raspberry Metabolites in the Urine Collected 24 Hours Before Surgery | At the baseline enrollment, subjects provided a spot urine sample. One day prior to surgery, subjects collected a 24-h urine sample. Spot urine samples were used to estimate individual ET exposure at baseline, but not specifically for comparison to 24-h urine sample collection at the close of the intervention. UPLC eluate was introduced to a triple quadrupole mass spectrometer (QuattroUltima,Waters Corp., Beverley,MA) via an electrospray mode operated in positive ion mode without splitting flow. Standards of urolithin A, B, C, D, methyl A, and dimethyl A were used for external calibration. Baseline urine analysis was determined from a spot urine collection and metabolite profiles were normalized to urinary creatinine levels. Final urinary analysis was based on a 24-h urine collection and metabolite profiles were normalized to 24-h urine volumes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Clinton | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33744235 | Background | Hill EB, Kennedy AJ, Roberts KM, Riedl KM, Grainger EM, Clinton SK. Considerations for Use of the Phenol-Explorer Database to Estimate Dietary (Poly)phenol Intake. J Acad Nutr Diet. 2021 May;121(5):833-834. doi: 10.1016/j.jand.2021.02.010. Epub 2021 Mar 17. No abstract available. | |
| 27813248 | Result | Roberts KM, Grainger EM, Thomas-Ahner JM, Hinton A, Gu J, Riedl KM, Vodovotz Y, Abaza R, Schwartz SJ, Clinton SK. Application of a low polyphenol or low ellagitannin dietary intervention and its impact on ellagitannin metabolism in men. Mol Nutr Food Res. 2017 Mar;61(3):10.1002/mnfr.201600224. doi: 10.1002/mnfr.201600224. Epub 2017 Jan 17. |
| Label | URL |
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| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Regular Diet) | Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| FG001 | Arm II (Low Polyphenol Diet) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Arm V (higher-dose black raspberry confection) | Experimental | Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection to consume orally each day for 4-6 weeks and then undergo prostatectomy. |
|
| Arm VI (lower-dose black raspberry nectar) | Experimental | Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy. |
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| Arm VII (higher-dose black raspberry nectar) | Experimental | Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy. |
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| laboratory biomarker analysis | Other | Correlative studies |
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| dietary intervention | Dietary Supplement | Follow a low polyphenol diet |
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| dietary intervention | Dietary Supplement | Follow a low ellagitannin diet |
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| quality-of-life assessment | Procedure | Ancillary studies |
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| questionnaire administration | Other | Ancillary studies |
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| 24 hours |
| Changes in PSA or PSA Doubling Time | Analyzed on the log scale using a repeated measures linear model to judge the effect of treatment group in terms of fold-differences from baseline while controlling for BMI and age. Confidence intervals for dichotomous variables will be made using exact methods and confidence intervals for rank correlations between quantitative variables will be made using Fisher's transformation. | Up to 6 weeks |
| Black Raspberry Metabolites Levels in the Prostate Tissue Removed at Surgery | Confidence intervals for dichotomous variables will be made using exact methods and confidence intervals for rank correlations between quantitative variables will be made using Fisher's transformation. | Up to 6 weeks |
| 32112501 | Result | Roberts KM, Grainger EM, Thomas-Ahner JM, Hinton A, Gu J, Riedl K, Vodovotz Y, Abaza R, Schwartz SJ, Clinton SK. Dose-Dependent Increases in Ellagitannin Metabolites as Biomarkers of Intake in Humans Consuming Standardized Black Raspberry Food Products Designed for Clinical Trials. Mol Nutr Food Res. 2020 May;64(10):e1900800. doi: 10.1002/mnfr.201900800. Epub 2020 Mar 17. |
Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low polyphenol diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| FG002 | Arm III (Low Ellagitannin Diet) | Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| FG003 | Arm IV (Lower-dose Lyophilized Black Raspberry Gummy) | Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry nectar: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| FG004 | Arm V (Higher-dose Black Raspberry Gummy) | Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry nectar: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| FG005 | Arm VI (Lower-dose Black Raspberry Confection) | Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| FG006 | Arm VII (Higher-dose Black Raspberry Confection) | Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Regular Diet) | Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| BG001 | Arm II (Low Polyphenol Diet) | Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low polyphenol diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| BG002 | Arm III (Low Ellagitannin Diet) | Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| BG003 | Arm IV (Lower-dose Lyophilized Black Raspberry Gummy) | Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry nectar: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| BG004 | Arm V (Higher-dose Black Raspberry Gummy) | Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry nectar: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| BG005 | Arm VI (Lower-dose Black Raspberry Confection) | Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| BG006 | Arm VII (Higher-dose Black Raspberry Confection) | Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Adverse Events Assessed Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 | Adverse events were measured by asking participants at each study visit about any new symptoms which may or may not be related to the intervention. No adverse events were reported from any subjects. | Posted | Count of Participants | Participants | Up to 30 days after completion of study treatment |
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| Primary | Percentage of Intervention Consumed | A cohort will be considered compliant if the group mean consumption of the intervention product is at least 80%. | Posted | Mean | Full Range | Percentage of intervention consumed | Up to 6-weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Concentration of Black Raspberry Metabolites in the Urine Collected 24 Hours Before Surgery | At the baseline enrollment, subjects provided a spot urine sample. One day prior to surgery, subjects collected a 24-h urine sample. Spot urine samples were used to estimate individual ET exposure at baseline, but not specifically for comparison to 24-h urine sample collection at the close of the intervention. UPLC eluate was introduced to a triple quadrupole mass spectrometer (QuattroUltima,Waters Corp., Beverley,MA) via an electrospray mode operated in positive ion mode without splitting flow. Standards of urolithin A, B, C, D, methyl A, and dimethyl A were used for external calibration. Baseline urine analysis was determined from a spot urine collection and metabolite profiles were normalized to urinary creatinine levels. Final urinary analysis was based on a 24-h urine collection and metabolite profiles were normalized to 24-h urine volumes. | We did not collect a 24 hour urine from men enrolled in the first two groups (regular diet and low polyphenol diet) | Posted | Mean | Full Range | Urolithin A in 24 hour urine (nmol/day) | 24 hours |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in PSA or PSA Doubling Time | Analyzed on the log scale using a repeated measures linear model to judge the effect of treatment group in terms of fold-differences from baseline while controlling for BMI and age. Confidence intervals for dichotomous variables will be made using exact methods and confidence intervals for rank correlations between quantitative variables will be made using Fisher's transformation. | Posted | Mean | Standard Deviation | PSA ng/mL | Up to 6 weeks |
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| Secondary | Black Raspberry Metabolites Levels in the Prostate Tissue Removed at Surgery | Confidence intervals for dichotomous variables will be made using exact methods and confidence intervals for rank correlations between quantitative variables will be made using Fisher's transformation. | We were only able to obtain enough prostate tissue for ellagitannin metabolite analysis in 8 men (4 subjects on the usual diet arm and 4 who were consuming the black raspberry food products). No metabolites were detected in any of the prostate tissue samples. | Posted | Mean | Full Range | nmol/g of prostate tissue | Up to 6 weeks |
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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 (Regular Diet) | Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies | 0 | 8 | 0 | 8 | 0 | 8 |
| EG001 | Arm II (Low Polyphenol Diet) | Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low polyphenol diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Arm III (Low Ellagitannin Diet) | Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy. laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | Arm IV (Lower-dose Lyophilized Black Raspberry Gummy) | Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry nectar: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies | 0 | 8 | 0 | 8 | 0 | 8 |
| EG004 | Arm V (Higher-dose Black Raspberry Gummy) | Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry nectar: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies | 0 | 8 | 0 | 8 | 0 | 8 |
| EG005 | Arm VI (Lower-dose Black Raspberry Confection) | Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies | 0 | 8 | 0 | 8 | 0 | 8 |
| EG006 | Arm VII (Higher-dose Black Raspberry Confection) | Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies | 0 | 8 | 0 | 8 | 0 | 8 |
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We were only able to obtain 8 prostate tissue samples after surgery. These samples did not have detectable ellagitannins, however because of the small number, we are unable to make any conclusions about ellagitannin uptake in tissue. Although our study provided important data on urinary metabolites of black raspberries and additional dietary data which will be useful for future research, our sample size was too small detect statistical significance for secondary objectives (PSA change).
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven K. Clinton | The Ohio State University | 614-293-2886 | steven.clinton@osumc.edu |
| 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 |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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| Male |
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| Arm IV (Lower-dose Lyophilized Black Raspberry Gummy) |
Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry nectar: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| OG004 | Arm V (Higher-dose Black Raspberry Gummy) | Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry nectar: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| OG005 | Arm VI (Lower-dose Black Raspberry Confection) | Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| OG006 | Arm VII (Higher-dose Black Raspberry Confection) | Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
|
|
Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry nectar: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| OG002 | Arm V (Higher-dose Black Raspberry Gummy) | Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry nectar: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| OG003 | Arm VI (Lower-dose Black Raspberry Confection) | Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| OG004 | Arm VII (Higher-dose Black Raspberry Confection) | Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
|
|
| OG003 | Arm IV (Lower-dose Lyophilized Black Raspberry Confection) | Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection each day for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| OG004 | Arm V (Higher-dose Black Raspberry Confection) | Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection to consume orally each day for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| OG005 | Arm VI (Lower-dose Black Raspberry Nectar) | Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| OG006 | Arm VII (Higher-dose Black Raspberry Nectar) | Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar for oral consumption daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
|
|
Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy.
laboratory biomarker analysis: Correlative studies
dietary intervention: Follow a low ellagitannin diet
quality-of-life assessment: Ancillary studies
questionnaire administration: Ancillary studies
| OG003 | Arm IV (Lower-dose Lyophilized Black Raspberry Gummy) | Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry nectar: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| OG004 | Arm V (Higher-dose Black Raspberry Gummy) | Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry nectar: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| OG005 | Arm VI (Lower-dose Black Raspberry Confection) | Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
| OG006 | Arm VII (Higher-dose Black Raspberry Confection) | Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy. lyophilized black raspberry confection: Given PO laboratory biomarker analysis: Correlative studies dietary intervention: Follow a low ellagitannin diet quality-of-life assessment: Ancillary studies questionnaire administration: Ancillary studies |
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