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

Stage III Prostate Cancer Clinical Trial

Official title:

Dietary Fruit Bioactives and Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01823562
• Other study ID #: OSU-12125
• Secondary ID: NCI-2013-00326
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: October 17, 2012
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: June 2025
• Est. primary completion date: August 1, 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer
• Stage III Prostate Cancer

Intervention

Drug:
• lyophilized black raspberry confection
Given PO

Other:
• laboratory biomarker analysis
Correlative studies

Dietary Supplement:
• dietary intervention
Follow a low polyphenol diet
• dietary intervention
Follow a low ellagitannin diet

Procedure:
• quality-of-life assessment
Ancillary studies

Other:
• questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0		Up to 30 days after completion of study treatment
Primary	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%.	Up to 6 weeks
Secondary	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.	Up to 6 weeks
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.	Up to 6 weeks
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.	Up to 6 weeks

External Links

•   The Jamesline