WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy
- Conditions
- Prostate Cancer
- Interventions
- Other: walnutsOther: usual dietOther: phone counseling with dietitian
- Registration Number
- NCT03824652
- Lead Sponsor
- Stephen Freedland
- Brief 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.
- Detailed 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 & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 50
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Diet + Walnuts walnuts Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks Usual Diet + Walnuts phone counseling with dietitian Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks Usual Diet usual diet Usual diet for 4-10 weeks Usual Diet + Walnuts usual diet Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks
- Primary Outcome Measures
Name Time Method Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP 10 weeks
- Secondary Outcome Measures
Name Time Method Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP 10 weeks Measured by prostate tissue 8-hydroxy-2-deoxyguanosine
Mean difference in prostatic tissue inflammation from baseline biopsy to RP 10 weeks Measured by 8-hydroxy-2-deoxyguanosine and immune cell infiltration
Trial Locations
- Locations (2)
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Durham VA Medical Center
🇺🇸Durham, North Carolina, United States