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This study has been withdrawn prior to enrollment.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:
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
  Purpose

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 Intervention
Stage III Prostate Cancer
Dietary Supplement: omega-3 fatty acid
Other: bone scan
Other: dual x-ray absorptometry
Other: laboratory biomarker analysis
Procedure: biopsy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: May 2011
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: biopsies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996749

Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
Principal Investigator: Majid Mirzazadeh Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00996749     History of Changes
Other Study ID Numbers: CCCWFU 85108, NCI-2009-01340
Study First Received: October 15, 2009
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014