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

This study has been withdrawn prior to enrollment.
(No Participants enrolled; slow accrual)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00996749
First received: October 15, 2009
Last updated: January 16, 2013
Last verified: January 2013
History of Changes

October 15, 2009
January 16, 2013
May 2011
January 2013   (final data collection date for primary outcome measure)
  • Omega-3 fatty acid levels in serum and fat biopsies [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
  • Omega-6 fatty acid levels in serum and fat biopsies [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
  • Tolerability of omega-3 fatty acid supplementation [ Time Frame: At 1 month ] [ Designated as safety issue: No ]
  • Tolerability of omega-3 fatty acid supplementation [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Tolerability of omega-3 fatty acid supplementation [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
  • Omega-3 fatty acid (FA) levels at 1 year [ Designated as safety issue: No ]
  • Omega-6 FA levels at 1 year [ Designated as safety issue: No ]
  • Tolerability of omega-3 FA supplementation [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00996749 on ClinicalTrials.gov Archive Site
  • Time to PSA progression [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
  • Rates of PSA progression [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
  • Status of bony metastasis [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Bone density as assessed by dual energy x-ray absorptiometry (DEXA) scan [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  • Bone density as assessed by DEXA scan [ Time Frame: At 1 year ] [ Designated as safety issue: No ]
  • Bone density at 1 year [ Designated as safety issue: No ]
  • Cancer-specific survival [ Designated as safety issue: No ]
  • Biochemical progression-free survival [ Designated as safety issue: No ]
  • Clinical recurrence-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Omega-3 Fatty Acids in Treating Patients With Advanced Prostate Cancer
Pilot Study to Determine the Optimal Dosage of Omega-3 Polyunsaturated Fatty Acid (PUFA) in Men With Advanced Prostate Cancer

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

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.
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stage III Prostate Cancer
  • 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 Name: biopsies
Experimental: Treatment (omega-3 fatty acid)
Patients receive long-term omega-3 PUFA supplementation PO.
Interventions:
  • Dietary Supplement: omega-3 fatty acid
  • Other: bone scan
  • Other: dual x-ray absorptometry
  • Other: laboratory biomarker analysis
  • Procedure: biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
January 2013   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00996749
CCCWFU 85108, NCI-2009-01340
Yes
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Principal Investigator: Majid Mirzazadeh Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP