Low-Fat Diet and Fish Oil in Men on Active Surveillance for Prostate Cancer
NCT02176902 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 107
Last updated 2025-02-10
Summary
This randomized phase II trial will evaluate if a low omega-6, high omega-3 fat diet combined with fish oil has the potential to delay disease progression in patients with prostate cancer undergoing active surveillance.
Conditions
- Adenocarcinoma of the Prostate
- Stage I Prostate Cancer
- Stage IIA Prostate Cancer
- Stage IIB Prostate Cancer
Interventions
- BEHAVIORAL
-
behavioral dietary intervention
Receive dietary counseling
- BEHAVIORAL
-
behavioral dietary intervention
Receive guidelines for low-fat diet
- DIETARY_SUPPLEMENT
-
omega-3 fatty acid
Given PO
- OTHER
-
laboratory biomarker analysis
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Pharmavite LLC
collaborator INDUSTRY -
Seafood Industry Research Fund
collaborator UNKNOWN -
Jonsson Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
William Aronson · Jonsson Comprehensive Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 80 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-11-01
- Primary Completion
- 2023-04-19
- Completion
- 2026-11-01
Countries
- United States
Study Locations
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