NCT00559195已完成2 期
Phase 2 Study Evaluating the Efficacy of Epoetin Beta (Neocormon®) For Fatigue and Quality of Life of Patients Receiving Palliative Care for a Solid Malignant Tumor
Centre Hospital Regional Universitaire de Limoges2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2005年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Fatigue
研究概览
简要总结
RATIONALE: Epoetin beta may cause the body to make more red blood cells and may help relieve fatigue in patients with malignant solid tumors receiving palliative care.
PURPOSE: This phase II trial is studying how well epoetin beta works in treating fatigue and anemia in patients receiving palliative care for malignant solid tumors.
详细描述
OBJECTIVES:
Primary
- Evaluate the impact of epoetin beta on fatigue and quality of life of patients receiving palliative care for malignant solid tumors.
Secondary
- Evaluate the impact of epoetin beta on hemoglobin level (increase > 2 g/dL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 主要目的
- Supportive Care
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed malignant solid tumor
- •No hematologic malignancy
- •Hemoglobin < 10.5 g/dL (anemic)
- •Receiving palliative care only
- •PATIENT CHARACTERISTICS:
- •Life expectancy > 6 months
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No chronic anemia requiring treatment (e.g., thalassemia or sickle cell disease)
- •No uncontrolled hypertension
- •No allergy to any drugs or components used in the study
- •Not a prisoner or under guardianship or trusteeship
- •No mental disability that impairs a clear understanding of the study requirements
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 2 months since prior specific anticancer therapy (e.g., chemotherapy, hormonal therapy, targeted therapy, or immunotherapy)
- •More than 1 month since prior and no concurrent participation in another clinical trial
排除标准
- 未提供
结局指标
主要结局
Fatigue
Quality of life
次要结局
- Hemoglobin level
研究者
研究点 (2)
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