The Role of COX-2 Mediated Prostaglandin Production on Paclitaxel-Induced Myalgias and Arthralgias.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Change in urinary PGE-M level after paclitaxel treatment
研究概览
简要总结
RATIONALE: Learning about pain in patients with cancer receiving paclitaxel may help plan treatment and may help patients live more comfortably. Studying samples of urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to muscle and joint pain.
PURPOSE: This phase I trial is studying the role of biomarkers in muscle pain and joint pain in patients with solid tumors receiving paclitaxel.
详细描述
OBJECTIVES:
Primary
- To determine the change in urinary prostaglandin E metabolite (PGE-M) level after paclitaxel treatment in patients with a variety of solid tumor malignancies.
- To determine whether a change in PGE-M level correlates with paclitaxel dose.
- To determine whether the change in urinary PGE-M level correlates with patient reporting of pain, as measured by a visual analog scale and the Brief Pain Inventory short form (BPI-SF).
Secondary
- To determine whether leukotriene levels are affected by paclitaxel treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in urinary PGE-M level after paclitaxel treatment
时间窗: Day 1 before paclitaxel treatment and day 4, after treatment
Change in amount of PGE-M in the urine from before administration of paclitaxel to 4 days after treatment.
次要结局
- Correlation of change in urinary PEG-M level and paclitaxel dose(Day 1 before paclitaxel treatment and day 4, after treatment)
- Correlation of urinary PEG-M level with pain(day 1 before paclitaxel treatment and day 4, after treatment)
- Change in urinary luekotriene E_4 level after paclitaxel treatment(day 1 before paclitaxel treatment and day 4, after treatment)
研究者
Jill Gilbert, MD
Associate Professor of Medicine; Director, Hematology/Oncology Fellowship Program; Section Chief, Solid Tumor Oncology; Medical Oncologist
Vanderbilt-Ingram Cancer Center