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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP
Secondary outcome measures
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
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Who is running the clinical trial?
Stephen FreedlandLead Sponsor
1 Previous Clinical Trials
138 Total Patients Enrolled
California Walnut CommissionOTHER
23 Previous Clinical Trials
36,602 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.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have used 5-alpha reductase inhibitors in the last 6 months.My biopsy shows a grade group 2 or higher.I have had radiation or cryotherapy for prostate cancer.I am planning to have prostate removal surgery.I have been diagnosed with prostate cancer.My biopsy involved more than 10 separate samples to pinpoint the cancer.I do not have any active cancer except for basal or squamous cell skin cancer.I am on a diet or taking omega-3 supplements.I have received hormone or antiandrogen therapy in the past.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Diet + Walnuts
- Group 2: Usual Diet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been enlisted in this medical investigation?
"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical study, which was initially posted on April 22nd 2019, is actively recruiting. Approximately 50 individuals must be recruited from 1 different healthcare facility."
Answered by AI
Is recruitment for this experiment ongoing?
"Affirmative, clinicaltrials.gov has indicated that this medical trial is actively searching for volunteers. It was first uploaded on April 22nd 2019 and most recently updated November 4th 2022; it requires 50 participants from one research centre."
Answered by AI
What health issues can arise from consuming walnuts?
"Walnuts have been evaluated in a Phase 2 trial, so its safety is rated as a 2. Despite the lack of evidence for efficacy, there has been some research that proves walnut consumption can be considered safe."
Answered by AI
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