50 Participants Needed

Walnuts for Prostate Cancer

Recruiting at 1 trial location
YC
Overseen ByYunhee Choi-Kuaea, MSW
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a randomized control trial testing the effect of walnut supplementation on prostate cancer progression in 50 men with biopsy confirmed prostate cancer and planning to undergo RP. Patients consented to the study will be randomly assigned to either continue their usual diets (control arm) or to the walnut arm for 4-10 weeks depending on the window between their consent date and the date for RP.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used certain prostate medications recently or are on a diet program with omega-3 supplements.

Is it safe for humans to consume walnuts?

Walnuts are generally safe for human consumption and are associated with health benefits like reduced risk of heart disease. However, specific safety data for walnuts in the context of prostate cancer treatment in humans is not detailed in the available research.12345

How does the walnut treatment for prostate cancer differ from other treatments?

The walnut treatment for prostate cancer is unique because it involves using a natural food source, walnuts, which are rich in nutrients and antioxidants, rather than traditional medical treatments like surgery or hormone therapy. This approach focuses on dietary intervention, which is not a standard treatment for prostate cancer.678910

What data supports the effectiveness of the treatment Walnuts for Prostate Cancer?

Research shows that a diet enriched with walnuts can slow the growth of prostate cancer tumors in mice, reducing both the number and size of tumors compared to a standard diet. This suggests that walnuts might have beneficial effects on prostate cancer, possibly due to their various bioactive compounds.124511

Who Is on the Research Team?

Stephen J. Freedland, MD | Cedars-Sinai

Stephen Freedland, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

Men over 18 with confirmed prostate cancer (Gleason score ≥7) who read and understand English, are planning to undergo radical prostatectomy, and can eat walnuts. Excluded are those with nut allergies, hormone therapy history, recent use of certain drugs for prostate issues, prior prostate treatments, serious other diseases or conditions affecting protocol adherence.

Inclusion Criteria

Willing to adhere to a usual diet with the possible addition of 2 oz of walnuts per day
My biopsy shows a grade group 2 or higher.
I am planning to have prostate removal surgery.
See 3 more

Exclusion Criteria

I have used 5-alpha reductase inhibitors in the last 6 months.
Individuals with psychological/mental conditions which can affect the consent process and/or their adherence to the protocol
I have had radiation or cryotherapy for prostate cancer.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either continue their usual diets or add 2 ounces of walnuts daily for 4-10 weeks

4-10 weeks
Baseline visit in conjunction with standard of care post-biopsy, final visit prior to RP

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Walnuts
Trial Overview The trial is examining if eating walnuts affects the progression of prostate cancer in men awaiting surgery. Participants will either continue their normal diet or add 2 oz of walnuts daily for 4-10 weeks before their operation. They'll be randomly assigned to one of these two groups.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Usual Diet + WalnutsExperimental Treatment3 Interventions
Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks
Group II: Usual DietActive Control1 Intervention
Usual diet for 4-10 weeks

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stephen Freedland

Lead Sponsor

Trials
2
Recruited
190+

California Walnut Commission

Collaborator

Trials
25
Recruited
36,700+

Published Research Related to This Trial

A diet supplemented with walnuts significantly reduced the establishment and growth of LNCaP human prostate cancer cells in nude mice, with only 18.7% of walnut-fed mice developing tumors compared to 44.0% in the control group.
The average tumor size in walnut-fed mice was about one-fourth that of the control diet mice, indicating that walnuts may slow tumor growth effectively.
A walnut-enriched diet reduces the growth of LNCaP human prostate cancer xenografts in nude mice.Reiter, RJ., Tan, DX., Manchester, LC., et al.[2021]
In a 12-month randomized crossover study involving 40 middle-aged men, consuming an average of 35 grams of walnuts daily did not significantly change serum prostate-specific antigen (PSA) levels compared to a control diet.
The findings indicate that short-term walnut consumption is unlikely to negatively impact PSA levels, suggesting it is safe for prostate health in otherwise normal men.
Lack of effect of walnuts on serum levels of prostate specific antigen: a brief report.Simon, JA., Tanzman, JS., Sabaté, J.[2019]
In a study of 47,299 men over 26 years, nut consumption was not linked to the incidence of prostate cancer (PCa) or PCa-specific mortality.
However, men who ate nuts five or more times a week after being diagnosed with PCa had a 34% lower overall mortality rate compared to those who consumed nuts less than once a month, suggesting potential benefits of nut consumption for overall health post-diagnosis.
Nut consumption and prostate cancer risk and mortality.Wang, W., Yang, M., Kenfield, SA., et al.[2019]

Citations

A walnut-enriched diet reduces the growth of LNCaP human prostate cancer xenografts in nude mice. [2021]
Lack of effect of walnuts on serum levels of prostate specific antigen: a brief report. [2019]
Nut consumption and prostate cancer risk and mortality. [2019]
A high-fat diet containing whole walnuts (Juglans regia) reduces tumour size and growth along with plasma insulin-like growth factor 1 in the transgenic adenocarcinoma of the mouse prostate model. [2022]
Urolithin A causes p21 up-regulation in prostate cancer cells. [2018]
Walnut-enriched diet reduces fasting non-HDL-cholesterol and apolipoprotein B in healthy Caucasian subjects: a randomized controlled cross-over clinical trial. [2022]
[Localized prostatic cancer. Survival and loss of life expectancy]. [2006]
Prevalence of prostate adenocarcinoma according to race in an university hospital. [2019]
Changing presentation of prostate cancer in a UK population--10 year trends in prostate cancer risk profiles in the East of England. [2021]
Screening by lower urinary tract symptoms vs asymptomatic prostate-specific antigen levels leading to radical prostatectomy in Danish men: tumour characteristics and treatment outcome. [2009]
Synchronous primary carcinomas of the bladder and prostate. [2006]
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