Lyophilized Black Raspberry in Treating Patients With Prostate Cancer Undergoing Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Ohio State University Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Steven Clinton, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01823562
First received: March 28, 2013
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

This Phase I/Ib trial is studying the absorption and metabolism of phytochemicals found in black raspberries. This knowledge will help us design future chemoprevention studies and assist in making future dietary recommendations for men at high risk for prostate cancer.


Condition Intervention Phase
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Drug: lyophilized black raspberry lozenge
Other: laboratory biomarker analysis
Dietary Supplement: dietary intervention
Procedure: therapeutic conventional surgery
Procedure: quality-of-life assessment
Other: questionnaire administration
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dietary Fruit Bioactives and Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
    A cohort will be considered successfully compliant if at least 6 out of 7 men in the cohort are compliant.


Secondary Outcome Measures:
  • Oxidative stress biomarkers in the serum [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Immune parameters in the plasma [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Antioxidant and berry metabolite levels in the prostate tissue removed at surgery [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
    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.

  • PSA response [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 56
Study Start Date: October 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (regular diet)
Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy.
Other: laboratory biomarker analysis
Correlative studies
Procedure: therapeutic conventional surgery
Undergo prostatectomy
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
Active Comparator: Arm II (low polyphenol diet)
Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy.
Other: laboratory biomarker analysis
Correlative studies
Dietary Supplement: dietary intervention
Follow low polyphenol diet
Other Names:
  • Dietary Modification
  • intervention, dietary
Procedure: therapeutic conventional surgery
Undergo prostatectomy
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
Active Comparator: Arm III (low ellagitannin diet)
Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy.
Other: laboratory biomarker analysis
Correlative studies
Dietary Supplement: dietary intervention
Low ellagitannin diet
Other Names:
  • Dietary Modification
  • intervention, dietary
Procedure: therapeutic conventional surgery
Undergo prostatectomy
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
Experimental: Arm IV (lower-dose lyophilized black raspberry gummy)
Patients follow a low ellagitannin diet and receive lower-dose black raspberry gummy PO daily for 4-6 weeks and then undergo prostatectomy.
Drug: lyophilized black raspberry lozenge
Given PO
Other Name: LBR lozenge
Other: laboratory biomarker analysis
Correlative studies
Dietary Supplement: dietary intervention
Low ellagitannin diet
Other Names:
  • Dietary Modification
  • intervention, dietary
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
Experimental: Arm V (higher-dose black raspberry gummy)
Patients follow a low ellagitannin diet and receive higher-dose black raspberry gummy PO daily for 4-6 weeks and then undergo prostatectomy.
Drug: lyophilized black raspberry lozenge
Given PO
Other Name: LBR lozenge
Other: laboratory biomarker analysis
Correlative studies
Dietary Supplement: dietary intervention
Low ellagitannin diet
Other Names:
  • Dietary Modification
  • intervention, dietary
Procedure: therapeutic conventional surgery
Undergo prostatectomy
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
Experimental: 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.
Drug: lyophilized black raspberry lozenge
Given PO
Other Name: LBR lozenge
Other: laboratory biomarker analysis
Correlative studies
Dietary Supplement: dietary intervention
Low ellagitannin diet
Other Names:
  • Dietary Modification
  • intervention, dietary
Procedure: therapeutic conventional surgery
Undergo prostatectomy
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
Experimental: 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.
Drug: lyophilized black raspberry lozenge
Given PO
Other Name: LBR lozenge
Other: laboratory biomarker analysis
Correlative studies
Dietary Supplement: dietary intervention
Low ellagitannin diet
Other Names:
  • Dietary Modification
  • intervention, dietary
Procedure: therapeutic conventional surgery
Undergo prostatectomy
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823562

Contacts
Contact: Elizabeth M. Grainger, PhD 614-293-7817 elizabeth.grainger@osumc.edu

Locations
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Steven K. Clinton    614-293-2886    Steven.clinton@osumc.edu   
Principal Investigator: Steven K. Clinton         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Steven Clinton Ohio State University Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Steven Clinton, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01823562     History of Changes
Other Study ID Numbers: OSU-12125, NCI-2013-00326
Study First Received: March 28, 2013
Last Updated: October 15, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Ohio State University Comprehensive Cancer Center:
Lyophilized Black Raspberry
Prostate Cancer
Surgery

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014