ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00996749
Recruitment Status : Withdrawn (No Participants enrolled; slow accrual)
First Posted : October 16, 2009
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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
Stage III Prostate Cancer Dietary Supplement: omega-3 fatty acid Other: bone scan Other: dual x-ray absorptometry Other: laboratory biomarker analysis Procedure: biopsy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
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 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: biopsies




Primary Outcome Measures :
  1. Omega-3 fatty acid levels in serum and fat biopsies [ Time Frame: At 1 year ]
  2. Omega-6 fatty acid levels in serum and fat biopsies [ Time Frame: At 1 year ]
  3. Tolerability of omega-3 fatty acid supplementation [ Time Frame: At 1 month ]
  4. Tolerability of omega-3 fatty acid supplementation [ Time Frame: At 6 months ]
  5. Tolerability of omega-3 fatty acid supplementation [ Time Frame: At 12 months ]

Secondary Outcome Measures :
  1. Time to PSA progression [ Time Frame: At 1 year ]
  2. Rates of PSA progression [ Time Frame: At 1 year ]
  3. Status of bony metastasis [ Time Frame: At baseline ]
  4. Bone density as assessed by dual energy x-ray absorptiometry (DEXA) scan [ Time Frame: At baseline ]
  5. Bone density as assessed by DEXA scan [ Time Frame: At 1 year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996749


Sponsors and Collaborators
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Investigators
Principal Investigator: Majid Mirzazadeh Wake Forest University Health Sciences

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00996749     History of Changes
Other Study ID Numbers: CCCWFU 85108
NCI-2009-01340 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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