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Aborption and Metabolism of Lyophilized Black Raspberry Food Products in Men With Prostate Cancer Undergoing Surgery

Primary Purpose

Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer

Status

Unknown status

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

lyophilized black raspberry confection

laboratory biomarker analysis

dietary intervention

quality-of-life assessment

questionnaire administration

About this trial

This is an interventional treatment trial for Stage I Prostate Cancer focused on measuring Lyophilized Black Raspberry, Prostate Cancer, Surgery

Eligibility Criteria

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Inclusion Criteria:

Have biopsy proven carcinoma of the prostate
Have chosen a radical prostatectomy for treatment of their disease after the medical team has presented all possible treatment options
Not be receiving neoadjuvant hormonal or chemotherapy (other clinical trials)
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Not currently taking berry dietary supplements, or "alternative" products (Acai berry, pomegranate, black raspberry, Optiberry, Juice Plus)
Have BUN/Cr (blood urea nitrogen and serum creatinine) within normal limits
Have liver enzymes within normal limits
Have complete blood count (CBC) within normal limits
Have prothrombin time/partial thromboplastin time (PT/PTT/INR) within normal limits
Voluntarily agree to participate and sign an informed consent document
Agree to have prostate biopsy blocks provided to the study for evaluation
Agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study
Agree to follow a controlled polyphenolic and/ or ellagitannin diet

Exclusion Criteria:

Have an active malignancy other than prostate cancer that requires therapy
Have a prostate biopsy with less than 5% cancer involvement
Have a history of traumatic or surgical castration
Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, adrenocorticotropic hormone [ACTH], growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes and osteoporosis
Are taking certain medications; no concurrent finasteride (Proscar) or other hormonal agents for chemoprevention/treatment of benign prostate hyperplasia (BPH); utilizing prescription medications for urinary outlet obstructive symptoms will not be permitted; the use of non-prescription substances to improve urinary tract symptoms will not be permitted (i.e. Saw Palmetto, other herbal, alternative products)
Have a known allergy to black raspberries, corn, and wheat products or those who have never consumed any of these products
Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, Celiac disease, irritable bowel syndrome [IBS]), renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome
Have significant loss of gastrointestinal organs due to surgery, except for appendix
Have altered immunity such as autoimmune disorders, cancer, anemia, hemophilia, and blood dyscrasias
Have noticeable open lesions in the oral cavity, sores that have not healed for more than 2 months or have a history of leukoplakia, tumors of the buccal cavity, throat, and lips
Have difficulty swallowing (dysphagia), pain with swallowing (odynophagia), salivary gland dysfunction, or xerostomia (dry mouth)
Are taking medications that inhibit clotting (warfarin sodium) or using prescribed oral rinses (Peridex)

Sites / Locations

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (regular diet)

Arm II (low polyphenol diet)

Arm III (low ellagitannin diet)

Arm IV (lower-dose lyophilized black raspberry gummy)

Arm V (higher-dose black raspberry gummy)

Arm VI (lower-dose black raspberry confection)

Arm VII (higher-dose black raspberry confection)

Arm Description

Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy.

Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy.

Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy.

Patients follow a low ellagitannin diet and receive lower-dose black raspberry gummy PO daily for 4-6 weeks and then undergo prostatectomy.

Patients follow a low ellagitannin diet and receive higher-dose black raspberry gummy PO daily for 4-6 weeks and then undergo prostatectomy.

Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy.

Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy.

Outcomes

Primary Outcome Measures

Adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Compliance determined by consumption of at least 80% of black raspberries (BRB) and positive tests for urinary berry metabolites

A cohort will be considered compliant if the group mean consumption of the intervention product is at least 80%.

Secondary Outcome Measures

Presence of black raspberry metabolites in the urine collected 24 hours before surgery

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 body mass index (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.

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.

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.

Full Information

NCT ID

NCT01823562

First Posted

March 28, 2013

Last Updated

October 21, 2021

Sponsor

Ohio State University Comprehensive Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT01823562

Brief Title

Aborption and Metabolism of Lyophilized Black Raspberry Food Products in Men With Prostate Cancer Undergoing Surgery

Official Title

Dietary Fruit Bioactives and Prostate Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 17, 2012 (Actual)

Primary Completion Date

August 1, 2013 (Actual)

Study Completion Date

June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ohio State University Comprehensive Cancer Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVES: I. To conduct a dose-escalation study to determine safety and compliance of varying lyophilized black raspberry (LBR) delivery vehicles (a gummy 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 receive lower-dose black raspberry gummy orally (PO) daily for 4-6 weeks and then undergo prostatectomy. ARM V: Patients follow a low ellagitannin diet and receive higher-dose black raspberry gummy PO daily for 4-6 weeks and then undergo prostatectomy. ARM VI: Patients follow a low ellagitannin diet and receive lower-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy. ARM VII: Patients follow a low ellagitannin diet and receive higher-dose black raspberry nectar PO daily for 4-6 weeks and then undergo prostatectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage I Prostate Cancer, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer

Keywords

Lyophilized Black Raspberry, Prostate Cancer, Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm I (regular diet)

Arm Type

Active Comparator

Arm Description

Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy.

Arm Title

Arm II (low polyphenol diet)

Arm Type

Active Comparator

Arm Description

Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy.

Arm Title

Arm III (low ellagitannin diet)

Arm Type

Active Comparator

Arm Description

Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy.

Arm Title

Arm IV (lower-dose lyophilized black raspberry gummy)

Arm Type

Experimental

Arm Description

Patients follow a low ellagitannin diet and receive lower-dose black raspberry gummy PO daily for 4-6 weeks and then undergo prostatectomy.

Arm Title

Arm V (higher-dose black raspberry gummy)

Arm Type

Experimental

Arm Description

Patients follow a low ellagitannin diet and receive higher-dose black raspberry gummy PO daily for 4-6 weeks and then undergo prostatectomy.

Arm Title

Arm VI (lower-dose black raspberry confection)

Arm Type

Experimental

Arm Description

Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy.

Arm Title

Arm VII (higher-dose black raspberry confection)

Arm Type

Experimental

Arm Description

Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy.

Intervention Type

Drug

Intervention Name(s)

lyophilized black raspberry confection

Other Intervention Name(s)

LBR confection

Intervention Description

Given PO

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Intervention Description

Correlative studies

Intervention Type

Dietary Supplement

Intervention Name(s)

dietary intervention

Other Intervention Name(s)

Dietary Modification, intervention, dietary

Intervention Description

Follow a low polyphenol diet

Intervention Type

Dietary Supplement

Intervention Name(s)

dietary intervention

Other Intervention Name(s)

Dietary Modification, intervention, dietary

Intervention Description

Follow a low ellagitannin diet

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Other Intervention Name(s)

quality of life assessment

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

questionnaire administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Time Frame

Up to 30 days after completion of study treatment

Title

Compliance determined by consumption of at least 80% of black raspberries (BRB) and positive tests for urinary berry metabolites

Description

A cohort will be considered compliant if the group mean consumption of the intervention product is at least 80%.

Time Frame

Up to 6 weeks

Secondary Outcome Measure Information:

Title

Presence of black raspberry metabolites in the urine collected 24 hours before surgery

Description

Time Frame

Up to 6 weeks

Title

Changes in PSA or PSA doubling time

Description

Time Frame

Up to 6 weeks

Title

Black Raspberry metabolites levels in the prostate tissue removed at surgery

Description

Time Frame

Up to 6 weeks

10. Eligibility

Sex

Male

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have biopsy proven carcinoma of the prostate Have chosen a radical prostatectomy for treatment of their disease after the medical team has presented all possible treatment options Not be receiving neoadjuvant hormonal or chemotherapy (other clinical trials) Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Not currently taking berry dietary supplements, or "alternative" products (Acai berry, pomegranate, black raspberry, Optiberry, Juice Plus) Have BUN/Cr (blood urea nitrogen and serum creatinine) within normal limits Have liver enzymes within normal limits Have complete blood count (CBC) within normal limits Have prothrombin time/partial thromboplastin time (PT/PTT/INR) within normal limits Voluntarily agree to participate and sign an informed consent document Agree to have prostate biopsy blocks provided to the study for evaluation Agree to consume a standardized vitamin and mineral supplement and avoid other nutrition, dietary, or alternative medications/supplements for the duration of the study Agree to follow a controlled polyphenolic and/ or ellagitannin diet Exclusion Criteria: Have an active malignancy other than prostate cancer that requires therapy Have a prostate biopsy with less than 5% cancer involvement Have a history of traumatic or surgical castration Have a history of pituitary hormone diseases that currently require supplemental hormonal administration (thyroid hormones, adrenocorticotropic hormone [ACTH], growth hormone) or other endocrine disorders requiring hormone administration with the exception of diabetes and osteoporosis Are taking certain medications; no concurrent finasteride (Proscar) or other hormonal agents for chemoprevention/treatment of benign prostate hyperplasia (BPH); utilizing prescription medications for urinary outlet obstructive symptoms will not be permitted; the use of non-prescription substances to improve urinary tract symptoms will not be permitted (i.e. Saw Palmetto, other herbal, alternative products) Have a known allergy to black raspberries, corn, and wheat products or those who have never consumed any of these products Have active metabolic or digestive illnesses such as malabsorptive disorders (Crohn's, Celiac disease, irritable bowel syndrome [IBS]), renal insufficiency, hepatic insufficiency, cachexia, or short bowel syndrome Have significant loss of gastrointestinal organs due to surgery, except for appendix Have altered immunity such as autoimmune disorders, cancer, anemia, hemophilia, and blood dyscrasias Have noticeable open lesions in the oral cavity, sores that have not healed for more than 2 months or have a history of leukoplakia, tumors of the buccal cavity, throat, and lips Have difficulty swallowing (dysphagia), pain with swallowing (odynophagia), salivary gland dysfunction, or xerostomia (dry mouth) Are taking medications that inhibit clotting (warfarin sodium) or using prescribed oral rinses (Peridex)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steven Clinton

Organizational Affiliation

Ohio State University Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

12. IPD Sharing Statement

Links:

URL

http://cancer.osu.edu

Description

The Jamesline

Learn more about this trial

Aborption and Metabolism of Lyophilized Black Raspberry Food Products in Men With Prostate Cancer Undergoing Surgery

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