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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03824652
• Other study ID #: IIT2018-23-Freedland-POWR
• Status: Recruiting
• Phase: Phase 2
• Start date: April 22, 2019
• Est. completion date: January 2026

Study information

• Verified date: April 2024
• Source: Cedars-Sinai Medical Center
• Contact: Yunhee Choi-Kuaea, MSW
• Phone: 310-423-0333
• Email: Yunhee.Choi-Kuaea[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Weight Loss

Intervention

Other:
• walnuts
2 ounces of walnuts daily for 4-10 weeks
• usual diet
Subject continues usual diet
• phone counseling with dietitian
Weekly calls with dietitian

Locations

Country	Name	City	State
United States	Durham VA Medical Center	Durham	North Carolina
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Stephen Freedland	California Walnut Commission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP		10 weeks
Secondary	Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP	Measured by prostate tissue 8-hydroxy-2-deoxyguanosine	10 weeks
Secondary	Mean difference in prostatic tissue inflammation from baseline biopsy to RP	Measured by 8-hydroxy-2-deoxyguanosine and immune cell infiltration	10 weeks