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

Stage III Prostate Cancer Clinical Trial

Official title:

Pilot Study to Determine the Optimal Dosage of Omega-3 Polyunsaturated Fatty Acid (PUFA) in Men With Advanced Prostate Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00996749
• Other study ID #: IRB00014553
• Secondary ID: NCI-2009-01340CC
• Status: Withdrawn
• Phase: N/A
• Start date: May 2011
• Est. completion date: January 2013

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Stage III Prostate Cancer

Intervention

Dietary Supplement:
• omega-3 fatty acid
Given PO

Other:
• bone scan
Correlative studies
• dual x-ray absorptometry
Correlative studies
• laboratory biomarker analysis
Correlative studies

Procedure:
• biopsy
Correlative studies

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Omega-3 fatty acid levels in serum and fat biopsies		At 1 year
Primary	Omega-6 fatty acid levels in serum and fat biopsies		At 1 year
Primary	Tolerability of omega-3 fatty acid supplementation		At 1 month
Primary	Tolerability of omega-3 fatty acid supplementation		At 6 months
Primary	Tolerability of omega-3 fatty acid supplementation		At 12 months
Secondary	Time to PSA progression		At 1 year
Secondary	Rates of PSA progression		At 1 year
Secondary	Status of bony metastasis		At baseline
Secondary	Bone density as assessed by dual energy x-ray absorptiometry (DEXA) scan		At baseline
Secondary	Bone density as assessed by DEXA scan		At 1 year