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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Stage III Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (omega-3 fatty acid)

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

Group Type EXPERIMENTAL

omega-3 fatty acid

Intervention Type DIETARY_SUPPLEMENT

Given PO

bone scan

Intervention Type OTHER

Correlative studies

dual x-ray absorptometry

Intervention Type OTHER

Correlative studies

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

biopsy

Intervention Type PROCEDURE

Correlative studies

Interventions

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omega-3 fatty acid

Given PO

Intervention Type DIETARY_SUPPLEMENT

bone scan

Correlative studies

Intervention Type OTHER

dual x-ray absorptometry

Correlative studies

Intervention Type OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

biopsy

Correlative studies

Intervention Type PROCEDURE

Other Intervention Names

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fish oil n-3 fatty acid O3FA DEXA scan dual energy x-ray absorptometry biopsies

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No