Omega-3 Fatty Acids in Treating Patients With Advanced Prostate Cancer

Wake Forest University (WFU)

Status: Withdrawn

Conditions: Stage III Prostate Cancer

Treatments: Dietary Supplement: omega-3 fatty acid; Other: bone scan; Other: dual x-ray absorptometry; Procedure: biopsy; Other: laboratory biomarker analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00996749

CCCWFU 85108 (Other Identifier)

NCI-2009-01340 (Registry Identifier)

IRB00014553

Details and patient eligibility

About

This phase I trial is studying the best way to give omega-3 fatty acids in treating patients with advanced prostate cancer. Omega-3 fatty acids may slow disease progression and may be an effective treatment for patients with advanced prostate cancer

Full description

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.

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment (omega-3 fatty acid)

Experimental group

Description:

Patients receive long-term omega-3 PUFA supplementation PO.

Treatment:

Procedure: biopsy

Other: dual x-ray absorptometry

Other: bone scan

Dietary Supplement: omega-3 fatty acid

Other: laboratory biomarker analysis