Prevention of Cancer/Treatment-Related Weight Loss in Children at High Nutritional Risk
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 14
- 主要终点
- Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline
研究概览
简要总结
RATIONALE: Cyproheptadine hydrochloride may prevent weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine is more effective than a placebo in preventing weight loss in young patients receiving chemotherapy for cancer.
PURPOSE: This randomized phase III trial is studying cyproheptadine hydrochloride to see how well it works in preventing weight loss in young patients receiving chemotherapy for cancer.
详细描述
OBJECTIVES:
Primary
- To determine the effect of cyproheptadine hydrochloride in the prevention of cancer- or treatment-related weight loss (defined as ≥ 5% reduction in weight from baseline measurement) in children who are initiating a course of moderately or highly emetic chemotherapy.
Secondary
- To investigate the effect of cyproheptadine HCl on the change in weight for age scores after 8 weeks of study drug administration in comparison to placebo.
- Investigate the relationship between the secondary outcome variables (prealbumin, triceps skin fold, mid-upper arm circumference, and weight loss)from baseline to end of treatment in each group (treatment and placebo) separately.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 21 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
Arm I cyproheptadine hydrochloride
Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.
干预措施: cyproheptadine hydrochloride (Drug)
Arm II placebo
Patients receive an oral placebo twice daily for 8 weeks.
干预措施: placebo (Other)
结局指标
主要结局
Participant With Weight Loss ≥ 5% at the 8- Week Assessment When Compared to Baseline
时间窗: 8 weeks
Severity of Weight Loss
时间窗: Baseline and 8 weeks
Change from Baseline in Weight Z score
次要结局
- Pattern of Weight in the Study Population(Baseline and 8 weeks)