WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy (NCT03824652) | Clinical Trial Compass
RecruitingPhase 2
WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy
United States50 participantsStarted 2019-04-22
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP