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

NCT01823562 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: OSU-12125NCI-2013-00326
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer

Keywords

Lyophilized Black Raspberry; Prostate Cancer; Surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

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

  Up to 6 weeks

• Changes in PSA or PSA doubling time

  Up to 6 weeks

• Black Raspberry metabolites levels in the prostate tissue removed at surgery

  Up to 6 weeks

Study Arms (7)

Arm I (regular diet)

ACTIVE COMPARATOR

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

Other: laboratory biomarker analysis; Procedure: quality-of-life assessment; Other: questionnaire administration

Arm II (low polyphenol diet)

ACTIVE COMPARATOR

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

Other: laboratory biomarker analysis; Dietary Supplement: dietary intervention; Procedure: quality-of-life assessment; Other: questionnaire administration

Arm III (low ellagitannin diet)

ACTIVE COMPARATOR

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

Other: laboratory biomarker analysis; Dietary Supplement: dietary intervention; Procedure: quality-of-life assessment; Other: questionnaire administration

Arm IV (lower-dose lyophilized black raspberry gummy)

EXPERIMENTAL

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 confection; Other: laboratory biomarker analysis; Dietary Supplement: dietary intervention; Procedure: quality-of-life assessment; Other: questionnaire administration

Arm V (higher-dose black raspberry gummy)

EXPERIMENTAL

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 confection; Other: laboratory biomarker analysis; Dietary Supplement: dietary intervention; Procedure: quality-of-life assessment; Other: questionnaire administration

Arm VI (lower-dose black raspberry confection)

EXPERIMENTAL

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 confection; Other: laboratory biomarker analysis; Dietary Supplement: dietary intervention; Procedure: quality-of-life assessment; Other: questionnaire administration

Arm VII (higher-dose black raspberry confection)

EXPERIMENTAL

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 confection; Other: laboratory biomarker analysis; Dietary Supplement: dietary intervention; Procedure: quality-of-life assessment; Other: questionnaire administration

Interventions

lyophilized black raspberry confection DRUG

Given PO

Also known as: LBR confection

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)

laboratory biomarker analysis OTHER

Correlative studies

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)

dietary intervention DIETARY_SUPPLEMENT

Follow a low polyphenol diet

Also known as: Dietary Modification, intervention, dietary

Arm II (low polyphenol diet)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

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)

questionnaire administration OTHER

Ancillary studies

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)

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Steven Clinton

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 4, 2013
• Study Start: October 17, 2012
• Primary Completion: August 1, 2013
• Study Completion: June 1, 2025
• Last Updated: March 4, 2025

Record last verified: 2025-03

Locations

US (1)