Status:
RECRUITING
WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy
Lead Sponsor:
Stephen Freedland
Collaborating Sponsors:
California Walnut Commission
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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 cons...
Detailed Description
The overall objective of this study is to test the effect of walnuts added to a usual diet on prostate cancer progression as measured by Ki67 expression in the prostate tissues. Subjects will be rando...
Eligibility Criteria
Inclusion
- Pathologically confirmed prostate adenocarcinoma.
- Diagnostic biopsy cores with ≥10 cores with each core examined separately to determine exact tumor location.
- Biopsy grade group 2 or higher (Gleason ≥7).
- Planning to undergo RP.
- Willing to adhere to a usual diet with the possible addition of 2 oz of walnuts per day.
- Reads, writes, and understands English.
- Age 18 or older
Exclusion
- Allergy to nuts.
- History of receiving hormone therapy or antiandrogen therapy.
- Use of 5-alpha reductase inhibitors in the past 6 months.
- Prior prostate radiotherapy (external beam or brachytherapy) or prior prostate cryotherapy.
- Currently enrolled in a modified diet/weight loss program and/or taking dietary supplements that contain omega-3s (e.g., fish oil).
- Other active malignancy, excluding basal cell carcinoma or squamous cell carcinoma
- Significant co-morbidities (e.g., cardiac, pulmonary, liver disease, alcohol/drug addiction, malabsorption syndromes), that in the opinion of the study physician make the patient ineligible.
- Individuals with psychological/mental conditions which can affect the consent process and/or their adherence to the protocol.
Key Trial Info
Start Date :
April 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03824652
Start Date
April 22 2019
End Date
December 1 2026
Last Update
August 22 2025
Active Locations (2)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Durham VA Medical Center
Durham, North Carolina, United States, 27705