Clinical trial NCT00996749: Omega-3 Fatty Acids in Treating Patients With Advanced Prostate Cancer
Official title: Pilot Study to Determine the Optimal Dosage of Omega-3 Polyunsaturated Fatty Acid (PUFA) in Men With Advanced Prostate Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stage III Prostate Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-10-16
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Omega-3 fatty acid levels in serum and fat biopsies
timeFrame: At 1 year
measure: Omega-6 fatty acid levels in serum and fat biopsies
timeFrame: At 1 year
measure: Tolerability of omega-3 fatty acid supplementation
timeFrame: At 1 month
measure: Tolerability of omega-3 fatty acid supplementation
timeFrame: At 6 months
measure: Tolerability of omega-3 fatty acid supplementation
timeFrame: At 12 months
Secondary outcomes:
measure: Time to PSA progression
timeFrame: At 1 year
measure: Rates of PSA progression
timeFrame: At 1 year
measure: Status of bony metastasis
timeFrame: At baseline
measure: Bone density as assessed by dual energy x-ray absorptiometry (DEXA) scan
timeFrame: At baseline
measure: Bone density as assessed by DEXA scan
timeFrame: At 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Majid Mirzazadeh
role: PRINCIPAL_INVESTIGATOR
References: