Effect of walnuts on prostate cancer progression
WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy
This study is testing whether adding walnuts to the diet can slow down prostate cancer progression in men preparing for surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT03824652 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of walnut supplementation on the progression of prostate cancer in men who are planning to undergo radical prostatectomy. Participants will be randomly assigned to either continue their usual diet or to include 2 ounces of walnuts daily for a period of 4-10 weeks. The primary outcome will be measured by assessing Ki67 expression in prostate tissues, which indicates cancer cell proliferation. The study aims to provide insights into dietary interventions that may influence cancer progression.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 or older with pathologically confirmed prostate adenocarcinoma who are planning to undergo radical prostatectomy.
Not a fit: Patients with allergies to nuts or those who have received prior hormone therapy or prostate radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a dietary approach to slow prostate cancer progression in affected patients.
How similar studies have performed: While dietary interventions in cancer treatment are being explored, this specific approach using walnuts is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Stephen Freedland, MD — Cedars-Sinai Medical Center
- Study coordinator: Clinical Trials Navigator
- Email: GroupCancerTrialInformation@cshs.org
- Phone: 310-423-0333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.