Clinical Trials /

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

NCT03824652

Description:

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy
  • Official Title: WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy

Clinical Trial IDs

  • ORG STUDY ID: IIT2018-23-Freedland-POWR
  • NCT ID: NCT03824652

Conditions

  • Prostate Cancer

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Usual Diet + WalnutsExperimentalUsual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks
    Usual DietActive ComparatorUsual diet for 4-10 weeks

      Eligibility Criteria

              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.
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:Male
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP
      Time Frame:10 weeks
      Safety Issue:
      Description:

      Secondary Outcome Measures

      Measure:Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP
      Time Frame:10 weeks
      Safety Issue:
      Description:Measured by prostate tissue 8-hydroxy-2-deoxyguanosine
      Measure:Mean difference in prostatic tissue inflammation from baseline biopsy to RP
      Time Frame:10 weeks
      Safety Issue:
      Description:Measured by 8-hydroxy-2-deoxyguanosine and immune cell infiltration

      Details

      Phase:Phase 2
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Stephen Freedland

      Trial Keywords

      • prostate cancer
      • prostate adenocarcinoma
      • diet
      • walnuts
      • radical prostatectomy
      • omega-3 fatty acids
      • polyphenols

      Last Updated

      April 13, 2020