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

Phase 2RecruitingNCT03824652

Stephen Freedland50 enrolled

Overview

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.

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 randomized 1:1 to usual diet or usual diet with the addition of 2 ounces of walnuts daily. The baseline visit will occur in conjunction with a standard of care visit post-biopsy, the intervention period will range from 4-10 weeks dependent upon the scheduled date of the standard of care radical prostatectomy (RP), and the final visit will occur in conjunction with a standard of care visit prior to RP.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

walnutsOTHER

2 ounces of walnuts daily for 4-10 weeks

usual dietOTHER

Subject continues usual diet

phone counseling with dietitianOTHER

Weekly calls with dietitian

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Cedars-Sinai Medical Center

Los Angeles, California, United States

RECRUITING

Outcomes

Primary Outcomes

Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP

Time frame: 10 weeks

Secondary Outcomes

Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP

Measured by prostate tissue 8-hydroxy-2-deoxyguanosine

Time frame: 10 weeks

Mean difference in prostatic tissue inflammation from baseline biopsy to RP

Measured by 8-hydroxy-2-deoxyguanosine and immune cell infiltration

Time frame: 10 weeks

Central Contacts

Clinical Trials Navigator

CONTACT

310-423-5842 GroupCancerTrialInformation@cshs.org

Data from ClinicalTrials.gov

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