Pilot Study to Determine the Optimal Dosage of Omega-3 Polyunsaturated Fatty Acid (PUFA) in Men With Advanced Prostate Cancer
OBJECTIVES:
I. To conduct a pilot study of omega-3 polyunsaturated fatty acid (PUFA) (omega-3 fatty
acid) supplementation in a group of patients with advanced prostate cancer to assess the
dose of omega-3 PUFA necessary to achieve an omega-6 to -3 ratio of 1:1 on an individual
basis and to assess the clinical impact of omega-3 supplementation on disease progression
OUTLINE:
Patients receive long-term omega-3 polyunsaturated fatty acid (PUFA) supplementation orally
(PO).
After completion of study treatment, patients are followed up at 1, 6, and 12 months.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Omega-3 fatty acid levels in serum and fat biopsies
At 1 year
No
Majid Mirzazadeh
Principal Investigator
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
CCCWFU 85108
NCT00996749
May 2011
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