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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00996749
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment
1
Arm
20.1
Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: omega-3 fatty acid
  • Other: bone scan
  • Other: dual x-ray absorptometry
  • Other: laboratory biomarker analysis
  • Procedure: biopsy
 N/A

Detailed Description

OBJECTIVES:
  1. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pilot Study to Determine the Optimal Dosage of Omega-3 Polyunsaturated Fatty Acid (PUFA) in Men With Advanced Prostate Cancer
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment (omega-3 fatty acid)

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

Dietary Supplement: omega-3 fatty acid
Given PO
Other Names:
  • fish oil
  • n-3 fatty acid
  • O3FA

    • Other: bone scan
    Correlative studies

    Other: dual x-ray absorptometry
    Correlative studies
    Other Names:
  • DEXA scan
  • dual energy x-ray absorptometry

    • Other: laboratory biomarker analysis
    Correlative studies

    Procedure: biopsy
    Correlative studies
    Other Names:
  • biopsies

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Omega-3 fatty acid levels in serum and fat biopsies [At 1 year]

    2. Omega-6 fatty acid levels in serum and fat biopsies [At 1 year]

    3. Tolerability of omega-3 fatty acid supplementation [At 1 month]

    4. Tolerability of omega-3 fatty acid supplementation [At 6 months]

    5. Tolerability of omega-3 fatty acid supplementation [At 12 months]

    Secondary Outcome Measures

    1. Time to PSA progression [At 1 year]

    2. Rates of PSA progression [At 1 year]

    3. Status of bony metastasis [At baseline]

    4. Bone density as assessed by dual energy x-ray absorptiometry (DEXA) scan [At baseline]

    5. Bone density as assessed by DEXA scan [At 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Wake Forest University Health Sciences
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Majid Mirzazadeh, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT00996749
    Other Study ID Numbers:
    • IRB00014553
    • NCI-2009-01340
    • CCCWFU 85108
    First Posted:
    Oct 16, 2009
    Last Update Posted:
    Jul 3, 2018
    Last Verified:
    Jul 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Jul 3, 2018