Epoetin Beta in Treating Fatigue and Anemia in Patients Receiving Palliative Care for Malignant Solid Tumors
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
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.
研究概览
详细说明
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).
OUTLINE: Patients receive epoetin beta subcutaneously once a week for up to 3 months.
Fatigue, quality of life, and hemoglobin and reticulocyte levels are assessed every 4 weeks.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
-
Limoges、法国、87042
- Centre Hospital Regional Universitaire de Limoges
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:非随机化
研究衡量的是什么?
主要结果指标
结果测量 |
---|
生活质量
|
疲劳
|
次要结果测量
结果测量 |
---|
血红蛋白水平
|
合作者和调查者
调查人员
- 学习椅:Jean-Luc Labourey、Centre Hospital Regional Universitaire de Limoges
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.