A Prospective, Randomized Pilot Study of Enbrel VS Placebo in Patients Receiving Radiation Therapy to Combat Fatigue and Cachexia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Determine if the subjects who received the enbrel study drug had a better quality of life than the subjects who received placebo
研究概览
简要总结
Patients who receive radiation therapy often have fatigue or a decrease in feeling well causing a "wasting" away. For patients with advanced disease of lung cancer, prostate cancer, or cancer that has spread to the bone, it is hoped that this drug may decrease this. If patients feel better during treatments they can complete the therapy without any breaks in treatment. For treatment to be most effective, it should be given in the amount needed, on a particular schedule.
详细描述
Subjects will be placed in a group to receive either the drug enbrel, or a placebo. The radiation therapy treatments are as they would be given if the person was not on a research study. The selection of the group a patient is in is done by random, like flipping a coin. The doctor is not able to influence which group anyone is selected for. As is done routinely, radiation therapy is given Monday through Friday for about 4 to 6 weeks.The injections of enbrel or placebo are given two times a week. The enbrel or placebo is given as an injection directly under the skin with a small needle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double
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
- •Advanced lung, prostate, or bony metastasis for cancer
- •Performance status (PS) of 3 or less
- •Good lab test results with albumin of at least 2.5
- •Radiation therapy of at least 4000Gy in 4 weeks
排除标准
- •Planned radiation therapy for less than 4 weeks or 4000Gy
- •Limited disease
结局指标
主要结局
Determine if the subjects who received the enbrel study drug had a better quality of life than the subjects who received placebo
次要结局
- Safety profile for enbrel taken by this group of individuals