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Search / Trial NCT03824652

WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy

Launched by STEPHEN FREEDLAND · Jan 29, 2019

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Prostate Cancer Prostate Adenocarcinoma Diet Walnuts Radical Prostatectomy Omega 3 Fatty Acids Polyphenols

ClinConnect Summary

The WALNUTS for POWER trial is studying whether adding walnuts to the diet can help slow down the progression of prostate cancer in men who have been diagnosed with this condition and are planning to undergo surgery called radical prostatectomy (RP). This research involves 50 men who will be randomly placed into two groups: one group will continue their regular diet, while the other group will include about 2 ounces of walnuts in their daily meals for a period of 4 to 10 weeks.

To qualify for this trial, participants need to have confirmed prostate cancer, specifically a type called adenocarcinoma, and have a certain level of tumor aggressiveness. They must also be at least 18 years old and able to understand and follow English instructions. However, men with nut allergies, certain previous treatments for prostate cancer, or significant health conditions may not be eligible. If you join the study, you can expect regular check-ins and to follow specific dietary guidelines during the study period. This trial aims to gather valuable information about how diet, particularly walnut consumption, might influence prostate cancer outcomes.

Gender

MALE

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.

About Stephen Freedland

Stephen Freedland is a distinguished clinical trial sponsor renowned for his innovative research in the field of urology and oncology. With a focus on prostate cancer, Dr. Freedland leads cutting-edge studies aimed at advancing treatment options and improving patient outcomes. His commitment to translating scientific discoveries into clinical practice is underscored by his collaboration with leading medical institutions and a dedication to rigorous trial design. By prioritizing patient-centered approaches, Dr. Freedland strives to enhance the understanding of cancer biology and develop effective therapeutic strategies that address the complexities of disease management.

Locations

Los Angeles, California, United States

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Stephen Freedland, MD

Principal Investigator

Cedars-Sinai Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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