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Phytochemical

lyophilized black raspberry confection for Prostate Cancer

Phase 1
Waitlist Available
Led By Steven Clinton
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have biopsy proven carcinoma of the prostate
Have liver enzymes within normal limits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days after completion of study treatment
Awards & highlights

Study Summary

"This trial is looking at how the body absorbs and processes natural compounds from black raspberries in men with prostate cancer. The results will help in planning future studies on preventing cancer and in making dietary recommendations for

Who is the study for?
Men with confirmed prostate cancer who have chosen surgery (radical prostatectomy) as their treatment and are not on hormone/chemotherapy or other clinical trials. They should not be taking berry supplements, must have normal kidney and liver function, normal blood counts, and clotting times. Participants need to be relatively healthy (ECOG status 0-1) and willing to consent.Check my eligibility
What is being tested?
The trial is examining how men with prostate cancer absorb and process compounds from black raspberries before their surgery. It involves eating a special raspberry confection, filling out questionnaires, undergoing lab tests for biomarkers related to cancer, and assessing quality of life.See study design
What are the potential side effects?
Since this study focuses on dietary intervention rather than medication or invasive procedures, side effects may be minimal but could include potential allergic reactions or gastrointestinal discomfort from the black raspberry products.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with prostate cancer through a biopsy.
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My liver function tests are normal.
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I am not currently on hormone or chemotherapy as part of another clinical trial.
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I am fully active or can carry out light work.
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I agree to follow a specific vitamin and mineral plan and not take other supplements during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after completion of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after completion of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
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
Secondary outcome measures
Black Raspberry metabolites levels in the prostate tissue removed at surgery
Changes in PSA or PSA doubling time
Presence of black raspberry metabolites in the urine collected 24 hours before surgery

Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: Arm VII (higher-dose black raspberry confection)Experimental Treatment5 Interventions
Patients follow a low ellagitannin diet and receive higher-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy.
Group II: Arm VI (lower-dose black raspberry confection)Experimental Treatment5 Interventions
Patients follow a low ellagitannin diet and receive lower-dose black raspberry confection PO daily for 4-6 weeks and then undergo prostatectomy.
Group III: Arm V (higher-dose black raspberry gummy)Experimental Treatment5 Interventions
Patients follow a low ellagitannin diet and receive higher-dose black raspberry gummy PO daily for 4-6 weeks and then undergo prostatectomy.
Group IV: Arm IV (lower-dose lyophilized black raspberry gummy)Experimental Treatment5 Interventions
Patients follow a low ellagitannin diet and receive lower-dose black raspberry gummy PO daily for 4-6 weeks and then undergo prostatectomy.
Group V: Arm III (low ellagitannin diet)Active Control4 Interventions
Patients follow a low ellagitannin diet for 4-6 weeks and then undergo prostatectomy.
Group VI: Arm I (regular diet)Active Control3 Interventions
Patients follow a regular diet for 4-6 weeks and then undergo prostatectomy.
Group VII: Arm II (low polyphenol diet)Active Control4 Interventions
Patients follow a low polyphenol diet for 4-6 weeks and then undergo prostatectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dietary intervention
2000
Completed Phase 2
~600
quality-of-life assessment
2012
Completed Phase 3
~2780

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,111 Total Patients Enrolled
10 Trials studying Prostate Cancer
2,170 Patients Enrolled for Prostate Cancer
Steven ClintonPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
35 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Aborption and Metabolism of Lyophilized Black Raspberry Food Products in Men With Prostate Cancer Undergoing Surgery
Steven Clinton 2012. "Aborption and Metabolism of Lyophilized Black Raspberry Food Products in Men With Prostate Cancer Undergoing Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01823562.
~4 spots leftby Apr 2025
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