Pilot Study to Determine the Optimal Dosage of Omega-3 Polyunsaturated Fatty Acid (PUFA) in Men With Advanced Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Omega-6 fatty acid levels in serum and fat biopsies
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment (omega-3 fatty acid)
Patients receive long-term omega-3 PUFA supplementation PO.
干预措施: biopsy (Procedure)
Treatment (omega-3 fatty acid)
Patients receive long-term omega-3 PUFA supplementation PO.
干预措施: omega-3 fatty acid (Dietary Supplement)
Treatment (omega-3 fatty acid)
Patients receive long-term omega-3 PUFA supplementation PO.
干预措施: bone scan (Other)
Treatment (omega-3 fatty acid)
Patients receive long-term omega-3 PUFA supplementation PO.
干预措施: dual x-ray absorptometry (Other)
Treatment (omega-3 fatty acid)
Patients receive long-term omega-3 PUFA supplementation PO.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Omega-6 fatty acid levels in serum and fat biopsies
时间窗: At 1 year
Tolerability of omega-3 fatty acid supplementation
时间窗: At 12 months
Omega-3 fatty acid levels in serum and fat biopsies
时间窗: At 1 year
次要结局
- Time to PSA progression(At 1 year)
- Rates of PSA progression(At 1 year)
- Status of bony metastasis(At baseline)
- Bone density as assessed by dual energy x-ray absorptiometry (DEXA) scan(At baseline)
- Bone density as assessed by DEXA scan(At 1 year)