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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the body absorbs and processes natural compounds from black raspberries in men scheduled for prostate cancer surgery. The goal is to gather information that could guide future cancer prevention studies and provide dietary advice for men at high risk of prostate cancer. Participants will either follow a specific diet alone or take black raspberry gummies or lyophilized black raspberry confections (a type of dietary supplement) in varying doses along with the diet. Men with confirmed prostate cancer who have decided on surgery and are not taking certain supplements or medications may be eligible to join.

As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this novel approach.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that black raspberry products, such as freeze-dried black raspberries, are generally safe for people. Other clinical studies have used these products without major safety issues. Studies suggest that both lower-dose and higher-dose black raspberry gummies and candies are well-tolerated.

These studies examine how the body absorbs and uses the natural compounds in black raspberries. So far, participants have reported no serious side effects, indicating that both lower and higher doses are safe. However, since this is an early study phase, the main goal is to ensure safety and determine the right dose. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for prostate cancer because they use lyophilized black raspberry products, offering a natural approach to therapy. Unlike traditional treatments such as surgery, radiation, or hormone therapy, these black raspberry gummies and confections may provide benefits through their rich antioxidant content, particularly ellagitannins, which are thought to have anti-cancer properties. Additionally, the delivery method as a daily edible gummy or confection makes it an easy and potentially pleasant treatment option. This innovative approach could offer a complementary strategy to existing treatments, potentially enhancing outcomes with fewer side effects.

What evidence suggests that this trial's treatments could be effective for prostate cancer?

Research has shown that black raspberries might help fight cancer. Studies have found that substances in black raspberries can slow cancer growth and reduce swelling. Specifically, black raspberries have lowered certain cancer indicators in prostate cancer patients. They also reduce inflammation and support the body's natural defenses against tumors. Early results suggest that consuming black raspberries might help manage prostate cancer by altering hormone levels and reducing cell damage. This trial will evaluate different doses of black raspberry products, including gummies and confections, to assess how well the body absorbs and uses these substances, potentially leading to better cancer prevention methods. ^{1 4 6 7 8}

Who Is on the Research Team?

Steven Clinton, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7012690/

EFFECTS OF BLACK RASPBERRIES AND THEIR ... Feeding black raspberries inhibited mammary cancer induction in rats and growth of cancer cells in nude mice, indicating systemic bioavailability of bioactive ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5008867/

Black raspberries in cancer clinical trials: Past, present and ... RESULTS. Research investigating BRB in clinical settings report positive effects on preneoplastic lesions or cancers of the oral cavity, esophagus and colon.

3. etd.ohiolink.edu etd.ohiolink.edu/acprod/odb_etd/ws/send_file/send?accession=osu1437646904&disposition=inline

Assessment of Black Raspberries for Prostate Cancer Ellagitannin were retained at 95% and 91% after processing of confection and nectar with the 20 g BRB dose in large-scale production. Nectar with lower BRB dose ...

4. withpower.com withpower.com/trial/phase-1-6-2013-7c819

Black Raspberry Confection for Healthy Subjects Research suggests that black raspberries may help reduce inflammation after eating a high-fat meal, as seen in a study with older overweight males.

5. oncohemakey.com oncohemakey.com/harnessing-natures-therapeutic-potential-a-review-of-natural-products-in-prostate-cancer-management/

A review of natural products in prostate cancer management This review explores the mechanisms of action of key natural products in prostate cancer management and summarizes clinical trials evaluating ...

6. withpower.com withpower.com/trial/phase-1-prostatic-neoplasms-9-2012-595eb

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 ...

7. app.trialscreen.org app.trialscreen.org/trials/phase-1-stage-prostate-cancer-aborption-metabolism-lyophilized-black-raspberry-trial-nct01823562

Aborption and Metabolism of Lyophilized Black Raspberry ... This Phase I/Ib trial is studying the absorption and metabolism of phytochemicals found in black raspberries in men undergoing surgery for ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9496378/

Dose-dependent increases in ellagitannin metabolites as ... Black raspberry (BRB) phytochemicals demonstrate anti-carcinogenic properties in experimental models, including prostate cancer.