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Pilot Study to Determine the Optimal Dosage of Omega-3 Polyunsaturated Fatty Acid (PUFA) in Men With Advanced Prostate Cancer


N/A
18 Years
N/A
Not Enrolling
Male
Stage III Prostate Cancer

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Trial Information

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.


Inclusion Criteria:



Disease is currently controlled with androgen ablation therapy Androgen ablation is
expected to continue for at least 1 year Has been treated with androgen ablation therapy
for at least 1 month Stable or decreasing prostate-specific antigen (PSA) on androgen
ablation therapy Stable or no visible metastatic disease on imaging Eastern Cooperative
Oncology Group (ECOG) functional status of at 0 or 1

Exclusion Criteria:

Eligible for local intervention with surgery or radiation Increasing serum PSA on hormonal
ablation Radiographic evidence of progression of disease on hormonal ablation Current or
history of second malignancy Previously treated with chemotherapeutic agents Previous
history of intermittent androgen therapy Gastrointestinal (GI) disease that impacts
absorption of nutrients

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Omega-3 fatty acid levels in serum and fat biopsies

Outcome Time Frame:

At 1 year

Safety Issue:

No

Principal Investigator

Majid Mirzazadeh

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 85108

NCT ID:

NCT00996749

Start Date:

May 2011

Completion Date:

Related Keywords:

  • Stage III Prostate Cancer
  • Prostatic Neoplasms

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