Overview

This trial is active, not recruiting.

Conditions stage i prostate cancer, stage iia prostate cancer, stage iib prostate cancer, stage iii prostate cancer
Treatments lyophilized black raspberry confection, laboratory biomarker analysis, dietary intervention, quality-of-life assessment, questionnaire administration
Phase phase 1
Sponsor Ohio State University Comprehensive Cancer Center
Start date October 2012
End date August 2013
Trial size 56 participants
Trial identifier NCT01823562, NCI-2013-00326, OSU-12125

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy.
laboratory biomarker analysis
Correlative studies
quality-of-life assessment quality of life assessment
Ancillary studies
questionnaire administration
Ancillary studies
(Active Comparator)
Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy.
laboratory biomarker analysis
Correlative studies
dietary intervention Dietary Modification
Follow a low polyphenol diet
quality-of-life assessment quality of life assessment
Ancillary studies
questionnaire administration
Ancillary studies
(Active Comparator)
Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy.
laboratory biomarker analysis
Correlative studies
dietary intervention Dietary Modification
Follow a low ellagitannin diet
quality-of-life assessment quality of life assessment
Ancillary studies
questionnaire administration
Ancillary studies
(Experimental)
Patients follow a low ellagitannin diet and receive lower-dose black raspberry gummy PO daily for 4-6 weeks and then undergo prostatectomy.
lyophilized black raspberry confection LBR confection
Given PO
laboratory biomarker analysis
Correlative studies
dietary intervention Dietary Modification
Follow a low ellagitannin diet
quality-of-life assessment quality of life assessment
Ancillary studies
questionnaire administration
Ancillary studies
(Experimental)
Patients follow a low ellagitannin diet and receive higher-dose black raspberry gummy PO daily for 4-6 weeks and then undergo prostatectomy.
lyophilized black raspberry confection LBR confection
Given PO
laboratory biomarker analysis
Correlative studies
dietary intervention Dietary Modification
Follow a low ellagitannin diet
quality-of-life assessment quality of life assessment
Ancillary studies
questionnaire administration
Ancillary studies
(Experimental)
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 LBR confection
Given PO
laboratory biomarker analysis
Correlative studies
dietary intervention Dietary Modification
Follow a low ellagitannin diet
quality-of-life assessment quality of life assessment
Ancillary studies
questionnaire administration
Ancillary studies
(Experimental)
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 LBR confection
Given PO
laboratory biomarker analysis
Correlative studies
dietary intervention Dietary Modification
Follow a low ellagitannin diet
quality-of-life assessment quality of life assessment
Ancillary studies
questionnaire administration
Ancillary studies

Primary Outcomes

Measure
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
Compliance determined by consumption of at least 80% of black raspberries (BRB) and positive tests for urinary berry metabolites
time frame: Up to 6 weeks

Secondary Outcomes

Measure
Presence of black raspberry metabolites in the urine collected 24 hours before surgery
time frame: Up to 6 weeks
Changes in PSA or PSA doubling time
time frame: Up to 6 weeks
Black Raspberry metabolites levels in the prostate tissue removed at surgery
time frame: Up to 6 weeks

Eligibility Criteria

Male participants of any age.

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)

Additional Information

Official title Dietary Fruit Bioactives and Prostate Cancer
Principal investigator Steven Clinton
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.