A Phase III Randomized Study Comparing The Effects Of Oxandrolone (Oxandrin) And Megestrol Acetate (Megace) On Lean Body Mass, Weight, Body Fat, And Quality Of Life In Patients With Solid Tumors And Weight Loss Receiving Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 20
- 主要终点
- Lean body mass as measured by the Bioelectrical Impedance Analysis monthly
研究概览
简要总结
RATIONALE: Oxandrolone and megestrol may help prevent weight loss and improve quality of life in patients with cancer. It is not yet known whether oxandrolone is more effective than megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors.
PURPOSE: This randomized phase III trial is studying oxandrolone to see how well it works compared to megestrol in preventing weight loss and improving quality of life in patients who are receiving chemotherapy for solid tumors.
详细描述
OBJECTIVES:
- Compare the lean body mass and weight of patients with solid tumors and weight loss who are receiving chemotherapy when treated with oxandrolone vs megestrol.
- Compare the health-related quality of life of patients treated with these drugs.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (I-III vs IV), concurrent radiotherapy (yes vs no), and gender. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral oxandrolone twice daily.
- Arm II: Patients receive oral megestrol once daily. In both arms, treatment continues for 12 weeks in the absence of excessive weight loss or gain or unacceptable toxicity.
Quality of life, weight, and body composition are assessed at baseline, at 1, 2, and 3 months during study therapy, and then at 1 month after study completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- None
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
研究组 & 干预措施
Arm 1 Oxandrolone 20 mg daily
Oxandrolone 20 mg (10 mg BID) for 12 weeks. 4 additional weeks of follow-up.
干预措施: Oxandrolone 20 mg (Drug)
Megace 800 mg
Megestrol acetate 800 mg daily for 12 weeks. 4 additional weeks of follow-up.
干预措施: Megestrol Acetate (Drug)
结局指标
主要结局
Lean body mass as measured by the Bioelectrical Impedance Analysis monthly
时间窗: 1 month intervals
次要结局
- Weight(1 month intervals)
- Body fat as measured by the Bioelectrical Impedance Analysis monthly(one month intervals)
- Toxicity as measured by standard NCI toxicity criteria(one month interval)
- Health-related quality of life as measured by the Functional Assessment of Cancer Therapy with subscales for anorexia/cachexia and fatigue(one month intervals)
- Performance status as measured by ECOG criteria(one month intervals)