NCT03824652 WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy
| NCT ID | NCT03824652 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Stephen Freedland |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2019-04-22 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2019-04-22 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Stephen Freedland, MD
PRINCIPAL INVESTIGATOR
Cedars-Sinai Medical Center
Frequently Asked Questions
Who can join the NCT03824652 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03824652 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03824652 currently recruiting?
Yes, NCT03824652 is actively recruiting participants. Contact the research team at GroupCancerTrialInformation@cshs.org for enrollment information.
Where is the NCT03824652 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT03824652 clinical trial?
NCT03824652 is sponsored by Stephen Freedland. The principal investigator is Stephen Freedland, MD at Cedars-Sinai Medical Center. The trial plans to enroll 50 participants.
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