Black Raspberry Products for Prostate Cancer

Age: Any Age

Sex: Male

Trial Phase: Phase 1

Sponsor: Ohio State University Comprehensive Cancer Center

Must not be taking: Hormonal agents, Anticoagulants

Disqualifiers: Active malignancy, Hormone disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

56 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial uses dried black raspberries in gummies and juice to see if they can help men having surgery for prostate cancer by changing hormone levels and reducing cancer-related markers.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications, especially those for prostate health like finasteride or other hormonal agents, and any non-prescription substances for urinary symptoms. You also need to avoid berry dietary supplements and certain alternative products during the study.

What data supports the effectiveness of the treatment Lyophilized Black Raspberry Confection for prostate cancer?

Research shows that black raspberries contain compounds with anti-cancer properties, and their components like ellagic acid have been found to inhibit prostate cancer cell growth at high concentrations. However, studies specifically on black raspberries for prostate cancer prevention have not shown significant effects, suggesting limited effectiveness due to low bioavailability of these compounds in the prostate. ^{1 2 3 4 5}

Is it safe to consume black raspberry products for prostate cancer?

Studies suggest that black raspberry products, like lyophilized black raspberries, are generally safe for human consumption, as they have been used in clinical trials without significant safety concerns. However, more research is needed to fully understand their effects, especially in specific conditions like prostate cancer. ^{1 3 4 5 6}

How is the lyophilized black raspberry confection treatment unique for prostate cancer?

The lyophilized black raspberry confection is unique because it uses natural compounds from black raspberries, which have shown potential anti-cancer properties in other types of cancer, although its effectiveness specifically for prostate cancer is not well-established. This treatment focuses on dietary intake of antioxidants and other bioactive compounds, which is different from conventional prostate cancer treatments like surgery, radiation, or hormone therapy. ^{1 3 4 7 8}

Research Team

Steven Clinton, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Have BUN/Cr (blood urea nitrogen and serum creatinine) within normal limits

Have prothrombin time/partial thromboplastin time (PT/PTT/INR) within normal limits

Agree to follow a controlled polyphenolic and/ or ellagitannin diet

Exclusion Criteria

Have a known allergy to black raspberries, corn, and wheat products or those who have never consumed any of these products

My prostate biopsy shows less than 5% cancer involvement.

I have trouble swallowing or experience pain when swallowing, and I may have dry mouth or issues with my salivary glands.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow specific dietary regimens and receive lyophilized black raspberry products for 4-6 weeks before undergoing prostatectomy

4-6 weeks

Follow-up

Participants are monitored for changes in PSA levels and black raspberry metabolite presence post-treatment

Up to 6 weeks

Treatment Details

Interventions

• Lyophilized Black Raspberry Confection

Trial Overview 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.

Participant Groups

Group I: Arm VII (higher-dose black raspberry confection) Experimental Treatment 5 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 Treatment 5 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 Treatment 5 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 Treatment 5 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 Control 4 Interventions

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

Group VI: Arm I (regular diet) Active Control 3 Interventions

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

Group VII: Arm II (low polyphenol diet) Active Control 4 Interventions

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

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Dose-Dependent Increases in Ellagitannin Metabolites as Biomarkers of Intake in Humans Consuming Standardized Black Raspberry Food Products Designed for Clinical Trials. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Food extracts consumed in Mediterranean countries and East Asia reduce protein concentrations of androgen receptor, phospho-protein kinase B, and phospho-cytosolic phospholipase A(2)alpha in human prostate cancer cells. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Effects of lyophilized black raspberries on azoxymethane-induced colon cancer and 8-hydroxy-2'-deoxyguanosine levels in the Fischer 344 rat. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of Black Raspberries and Their Constituents on Rat Prostate Carcinogenesis and Human Prostate Cancer Cell Growth In Vitro. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Characterization of black raspberry functional food products for cancer prevention human clinical trials. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

An Open-Label Randomized Crossover Trial of Lyophilized Black Raspberries on Postprandial Inflammation in Older Overweight Males: A Pilot Study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A phase I pilot study evaluating the beneficial effects of black raspberries in patients with Barrett's esophagus. [2019]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Black raspberries in cancer clinical trials: Past, present and future. [2020]