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

Primary Purpose

Stage III Prostate Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
omega-3 fatty acid
bone scan
dual x-ray absorptometry
laboratory biomarker analysis
biopsy
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage III Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment (omega-3 fatty acid)

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Omega-3 fatty acid levels in serum and fat biopsies
    Omega-6 fatty acid levels in serum and fat biopsies
    Tolerability of omega-3 fatty acid supplementation
    Tolerability of omega-3 fatty acid supplementation
    Tolerability of omega-3 fatty acid supplementation

    Secondary Outcome Measures

    Time to PSA progression
    Rates of PSA progression
    Status of bony metastasis
    Bone density as assessed by dual energy x-ray absorptiometry (DEXA) scan
    Bone density as assessed by DEXA scan

    Full Information

    First Posted
    October 15, 2009
    Last Updated
    July 2, 2018
    Sponsor
    Wake Forest University Health Sciences
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00996749
    Brief Title
    Omega-3 Fatty Acids in Treating Patients With Advanced Prostate Cancer
    Official Title
    Pilot Study to Determine the Optimal Dosage of Omega-3 Polyunsaturated Fatty Acid (PUFA) in Men With Advanced Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No Participants enrolled; slow accrual
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wake Forest University Health Sciences
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stage III Prostate Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment (omega-3 fatty acid)
    Arm Type
    Experimental
    Arm Description
    Patients receive long-term omega-3 PUFA supplementation PO.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    omega-3 fatty acid
    Other Intervention Name(s)
    fish oil, n-3 fatty acid, O3FA
    Intervention Description
    Given PO
    Intervention Type
    Other
    Intervention Name(s)
    bone scan
    Intervention Description
    Correlative studies
    Intervention Type
    Other
    Intervention Name(s)
    dual x-ray absorptometry
    Other Intervention Name(s)
    DEXA scan, dual energy x-ray absorptometry
    Intervention Description
    Correlative studies
    Intervention Type
    Other
    Intervention Name(s)
    laboratory biomarker analysis
    Intervention Description
    Correlative studies
    Intervention Type
    Procedure
    Intervention Name(s)
    biopsy
    Other Intervention Name(s)
    biopsies
    Intervention Description
    Correlative studies
    Primary Outcome Measure Information:
    Title
    Omega-3 fatty acid levels in serum and fat biopsies
    Time Frame
    At 1 year
    Title
    Omega-6 fatty acid levels in serum and fat biopsies
    Time Frame
    At 1 year
    Title
    Tolerability of omega-3 fatty acid supplementation
    Time Frame
    At 1 month
    Title
    Tolerability of omega-3 fatty acid supplementation
    Time Frame
    At 6 months
    Title
    Tolerability of omega-3 fatty acid supplementation
    Time Frame
    At 12 months
    Secondary Outcome Measure Information:
    Title
    Time to PSA progression
    Time Frame
    At 1 year
    Title
    Rates of PSA progression
    Time Frame
    At 1 year
    Title
    Status of bony metastasis
    Time Frame
    At baseline
    Title
    Bone density as assessed by dual energy x-ray absorptiometry (DEXA) scan
    Time Frame
    At baseline
    Title
    Bone density as assessed by DEXA scan
    Time Frame
    At 1 year

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Majid Mirzazadeh
    Organizational Affiliation
    Wake Forest University Health Sciences
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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