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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

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 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

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

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.

Media Library

walnuts Clinical Trial Eligibility Overview. Trial Name: NCT03824652 — Phase 2
Prostate Cancer Research Study Groups: Usual Diet + Walnuts, Usual Diet
Prostate Cancer Clinical Trial 2023: walnuts Highlights & Side Effects. Trial Name: NCT03824652 — Phase 2
walnuts 2023 Treatment Timeline for Medical Study. Trial Name: NCT03824652 — Phase 2
~2 spots leftby Jan 2025
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