An Open Label Randomized Phase II Study of an Appetite Stimulant, Cyproheptadine Hydrochloride, With and Without a Nutritional Supplement, in Children With Cancer/Treatment-Related Weight Loss
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 主要终点
- Difference Between Measures of Weight at Baseline and at Week 24
研究概览
简要总结
RATIONALE: Cyproheptadine hydrochloride may help improve appetite and lessen weight loss caused by cancer or cancer treatment. It is not yet known whether cyproheptadine hydrochloride is more effective with or without nutritional supplementation in improving weight and quality of life of young patients with weight loss caused by cancer or cancer treatment.
PURPOSE: This randomized phase II trial is studying cyproheptadine hydrochloride to see how well it works when given together with or without nutritional supplementation in treating young patients with weight loss caused by cancer or cancer treatment.
详细描述
OBJECTIVES:
Primary
- To compare the efficacy of an appetite stimulant, cyproheptadine hydrochloride, with vs without a nutritional supplement, PediaSure or Ensure, in improving weight and extending the duration of response in pediatric patients with cancer- or cancer treatment-related weight loss.
Secondary
- To compare patterns of body composition and weight change in patients treated with these regimens.
- To compare the change in the relationship between pre-albumin (biomarker of malnutrition) and weight improvement from baseline to the completion of study treatment.
- To compare the change in quality of life as measured by the Pediatric Functional Assessment of Anorexia and Cachexia Therapy (FAACT) questionnaire in patients treated with these regimens.
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
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 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 up to 24 weeks in the absence of weight loss or unacceptable toxicity.
干预措施: cyproheptadine hydrochloride (Drug)
cyproheptadine HCl & PediaSure or Ensure
Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
干预措施: Ensure (Dietary Supplement)
cyproheptadine HCl & PediaSure or Ensure
Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
干预措施: PediaSure (Dietary Supplement)
cyproheptadine HCl & PediaSure or Ensure
Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
干预措施: cyproheptadine hydrochloride (Drug)
结局指标
主要结局
Difference Between Measures of Weight at Baseline and at Week 24
时间窗: 24 weeks
Difference in measure of weight in kilograms of subject at baseline and at week 24 after continuing on study treatment for the entire 24 week period.
次要结局
- Body Mass Index as Assessed at Baseline and 24 Weeks(24 weeks)
- Effect of Cyproheptadine Hydrochloride on Pre-albumin and Body Composition(24 weeks)
- Quality of Life as Assessed by Peds-FAACT Questionnaire at Baseline and at Weeks 4 and 24(24 weeks)
- Change in Weight for Age Z-score From Baseline Through 24 Weeks(Baseline and 24 weeks)