The Effect of Cyproheptadine Hydrochloride (Periactin) and Megestrol Acetate (Megace) on Weight in Children With Cancer/Treatment Related Cachexia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 43
- 主要终点
- Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment
研究概览
简要总结
RATIONALE: Cyproheptadine and megestrol may improve appetite and help prevent weight loss in children with cancer.
PURPOSE: This phase II trial is studying how well cyproheptadine and megestrol work in improving appetite and preventing weight loss in children with cachexia caused by cancer or cancer treatment.
详细描述
OBJECTIVES:
- Determine the efficacy of cyproheptadine in preventing further weight loss in children with cancer or cancer treatment-related cachexia.
- Determine the efficacy of megestrol in preventing further weight loss in patients who don't respond to cyproheptadine.
- Determine how these drugs affect body protein and fat levels in these patients.
OUTLINE: Patients receive oral cyproheptadine twice daily for 4 weeks in the absence of unacceptable weight loss or toxicity. Patients that present with weight loss after 4 weeks receive oral megestrol daily for 4 weeks in the absence of unacceptable weight loss or toxicity. Patients responding to either cyproheptadine or megestrol may continue treatment at the discretion of the treating physician.
Patients are followed at 4 weeks.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 20 Years（Child, 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
Subjects that respond to Periactin
Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.
干预措施: cyproheptadine hydrochloride (Drug)
Non-responders to Periactin- Megace Arm
Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.
干预措施: cyproheptadine hydrochloride (Drug)
Non-responders to Periactin- Megace Arm
Receive 0.25mg/kg cyproheptadine hydrochloride once daily for 4 weeks. If subject responds to treatment (stable or increased weigh), go off study. If subject does not respond (loses weigh), subject will switch to10 mg/lg/day of megestrol acetate for 4 weeks.
干预措施: megestrol acetate (Drug)
结局指标
主要结局
Efficacy of study agents as measured by changes in weight at baseline, and 4 weeks after the beginning of study treatment
时间窗: 4-8 weeks
次要结局
- Effect of study agents on protein and fat levels as measured by pre-albumin and lipid profile at baseline, and 4 weeks after the beginning of study treatment(4-8 weeks)