RecruitingPhase 2NCT03824652

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

Sponsor

Stephen Freedland

Enrollment

50 participants

Start Date

Apr 22, 2019

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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

Sex: MALEMin Age: 18 Years

Inclusion Criteria7

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 Criteria8

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.