- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03824652
WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy
April 13, 2024 updated by: Stephen Freedland
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yunhee Choi-Kuaea, MSW
- Phone Number: 310-423-0333
- Email: Yunhee.Choi-Kuaea@cshs.org
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Recruiting
- Cedars-Sinai Medical Center
-
Contact:
- Yunhee Choi-Kuaea, MSW
- Phone Number: 310-423-0333
- Email: Yunhee.Choi-Kuaea@cshs.org
-
Principal Investigator:
- Stephen Freedland, MD
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Recruiting
- Durham VA Medical Center
-
Contact:
- Aubrey Jarman, RD
- Phone Number: 919-286-0411
- Email: Aubrey.Jarman@va.gov
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Usual Diet + Walnuts
Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks
|
2 ounces of walnuts daily for 4-10 weeks
Subject continues usual diet
Weekly calls with dietitian
|
Active Comparator: Usual Diet
Usual diet for 4-10 weeks
|
Subject continues usual diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP
Time Frame: 10 weeks
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP
Time Frame: 10 weeks
|
Measured by prostate tissue 8-hydroxy-2-deoxyguanosine
|
10 weeks
|
Mean difference in prostatic tissue inflammation from baseline biopsy to RP
Time Frame: 10 weeks
|
Measured by 8-hydroxy-2-deoxyguanosine and immune cell infiltration
|
10 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen Freedland, MD, Cedars-Sinai Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 22, 2019
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
January 29, 2019
First Submitted That Met QC Criteria
January 29, 2019
First Posted (Actual)
January 31, 2019
Study Record Updates
Last Update Posted (Actual)
April 16, 2024
Last Update Submitted That Met QC Criteria
April 13, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT2018-23-Freedland-POWR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on walnuts
-
The George Institute for Global Health, ChinaNingxia Medical UniversityCompletedCardiovascular Diseases | DyslipidemiasChina
-
National Research Council, SpainIMDEA Food; CEIP (primary school) Jara Carrillo (Alcantarilla, Murcia, Spain); IES (secondary school) Alcántara (Alcantarilla, Murcia, Spain)CompletedGenotype, Metabotype and Dietary HabitsSpain
-
University of California, DavisCalifornia Walnut CommissionCompletedImmune Function | Cardiovascular HealthUnited States
-
UConn HealthNational Cancer Institute (NCI); National Institutes of Health (NIH); University... and other collaboratorsRecruiting
-
Sophie Bucher Della TorreUniversity Hospital, GenevaActive, not recruiting
-
UConn HealthCalifornia Walnut Commission; American Institute for Cancer Research; The Jackson...CompletedColon Cancer | Colo-rectal Cancer | Diet HabitUnited States
-
University of California, San FranciscoCompletedPreDiabetes | Overweight and ObesityUnited States
-
Ludwig-Maximilians - University of MunichCompleted
-
Christos MantzorosCalifornia Walnut CommissionCompletedCardiovascular Disease | Metabolic Syndrome | Type 2 DiabetesUnited States
-
University of BelgradeCentre of Research Excellence in Nutrition and MetabolismCompletedHypertension | Metabolic Syndrome | Cardiovascular Risk FactorSerbia