RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2019-04-22
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03824652

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pathologically confirmed prostate adenocarcinoma.
  2. * Diagnostic biopsy cores with ≥10 cores with each core examined separately to determine exact tumor location.
  3. * Biopsy grade group 2 or higher (Gleason ≥7).
  4. * Planning to undergo RP.
  5. * Willing to adhere to a usual diet with the possible addition of 2 oz of walnuts per day.
  6. * Reads, writes, and understands English.
  7. * Age 18 or older
  1. * Allergy to nuts.
  2. * History of receiving hormone therapy or antiandrogen therapy.
  3. * Use of 5-alpha reductase inhibitors in the past 6 months.
  4. * Prior prostate radiotherapy (external beam or brachytherapy) or prior prostate cryotherapy.
  5. * Currently enrolled in a modified diet/weight loss program and/or taking dietary supplements that contain omega-3s (e.g., fish oil).
  6. * Other active malignancy, excluding basal cell carcinoma or squamous cell carcinoma
  7. * 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.
  8. * Individuals with psychological/mental conditions which can affect the consent process and/or their adherence to the protocol.

Contacts and Locations

Study Contact

Yunhee Choi-Kuaea, MSW
CONTACT
310-423-0333
Yunhee.Choi-Kuaea@cshs.org

Principal Investigator

Stephen Freedland, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center
Los Angeles, California, 90048
United States
Durham VA Medical Center
Durham, North Carolina, 27705
United States

Collaborators and Investigators

Sponsor: Stephen Freedland

  • Stephen Freedland, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2019-04-22
Study Completion Date2026-01

Study Record Updates

Study Start Date2019-04-22
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Prostate Cancer