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Walnuts for Prostate Cancer

Phase 2

Recruiting

Led By Stephen Freedland, MD

Research Sponsored by Stephen Freedland

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

History of receiving hormone therapy or antiandrogen therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether walnuts can help slow the progression of prostate cancer in men who are scheduled for surgery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves dietary changes by adding walnuts to the usual diet, side effects may include potential allergic reactions for those sensitive to nuts and possible digestive changes due to increased fiber intake.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have received hormone or antiandrogen therapy in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Mean difference in prostatic tissue inflammation from baseline biopsy to RP

Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stephen FreedlandLead Sponsor

1 Previous Clinical Trials

138 Total Patients Enrolled

California Walnut CommissionOTHER

24 Previous Clinical Trials

36,626 Total Patients Enrolled

Stephen Freedland, MD5.05 ReviewsPrincipal Investigator - Cedars-Sinai Medical Center

Cedars-Sinai Medical Center

1 Previous Clinical Trials

22 Total Patients Enrolled

1 Trials studying Prostate Cancer

22 Patients Enrolled for Prostate Cancer

5Patient Review

Dr. Freedland was excellent. They reviewed my previous diagnosis from another well-known healthcare organization and found that I needed the same surgery that I had 2 years ago. However, they used the Green Light laser surgery which had unbelievable results. I was only in pain for one day and had a much quicker and easier recovery than last time.