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

Stephen Freedland

Status and phase: Enrolling; Phase 2

Conditions: Prostate Cancer

Treatments: Other: usual diet; Other: phone counseling with dietitian; Other: walnuts

Study type: Interventional

Funder types: Other

Identifiers

NCT03824652

IIT2018-23-Freedland-POWR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Usual Diet + Walnuts

Experimental group

Description:

Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks

Treatment:

Other: walnuts

Other: phone counseling with dietitian

Other: usual diet

Usual Diet

Active Comparator group

Description:

Usual diet for 4-10 weeks

Treatment:

Other: usual diet