NCT00624962撤回不适用
Pilot Study of Early Enteral Tube Feedings in Children Receiving Chemotherapy for Newly Diagnosed AML/MDS and High Risk Solid Tumors
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Successful administration of enteral feedings via a nasogastric tube for 50% or more of the total nutritional-support days
研究概览
简要总结
RATIONALE: Tubefeeding may help maintain good nutrition and lessen weight loss in younger patients receiving chemotherapy for cancer.
PURPOSE: This clinical trial is studying how well tube feedings work in younger patients receiving chemotherapy for newly diagnosed acute myeloid leukemia, myelodysplastic syndrome, or high-risk solid tumors.
详细描述
OBJECTIVES:
Primary
- To determine the feasibility and acceptance of undertaking early enteral tube feedings in children receiving induction chemotherapy for newly diagnosed acute myeloid leukemia or myelodysplastic syndromes, primary cancers of the central nervous system, or high-risk solid tumors.
Secondary
- To determine the safety of proactive enteral nutrition in these patients.
- To evaluate the effect of enteral nutrition on nutritional status in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly confirmed diagnosis of 1 of the following:
- •Acute myeloid leukemia
- •Myelodysplastic syndromes
- •Any other stage IV solid tumor including:
- •Neuroblastoma
- •Hepatoblastoma
- •Any primary cancer of the central nervous system including:
- •Cerebellar astrocytoma
- •Medulloblastoma
- •Ependymoma
- •Spine tumors
排除标准
- •No contraindication to enteral tube feeding including, but not limited to, any of the following:
- •Gastrointestinal tract dysfunction (i.e., ileus, peritonitis, obstruction)
- •Active sinusitis (can be waived for patients with gastrostomy tubes)
- •Obstructive tumor in the nasopharynx
- •PRIOR CONCURRENT THERAPY:
- •No prior hematopoietic stem cell transplant
- •All clinically indicated medications are permitted during the course of the study
- •No other concurrent nutritional supplements
研究组 & 干预措施
Correlative/Supportive Care
Other
干预措施: nutritional intervention (Dietary Supplement)
Correlative/Supportive Care
Other
干预措施: therapeutic nutritional supplementation (Dietary Supplement)
结局指标
主要结局
Successful administration of enteral feedings via a nasogastric tube for 50% or more of the total nutritional-support days
时间窗: 50% or more of the total nutritional support days.
次要结局
- Number of times tubes replaced and number of subjects refusing replacement
- Duration of hospitalization
- Need for post-discharge nutritional support
- Number of patients accepting early insertion of enteral feeding tube for an approximate twelve week period(twelve weeks)
- Grade 3/4 gastrointestinal toxicity associated with enteral support
- Time to achieve primary goal of meeting 70% of nutritional needs by enteral intake and days maintained at this level(Not indicated)
- Complications associated with tube placement
- Nutritional status assessment on enrollment in study, beginning of course 1, and end of study period (week 12 or beginning of course 5 chemotherapy(week 12 or beginning course of Chemotherapy)
- Days of enteral (tube feeding) and total parenteral nutrition
研究者
John B. Pietsch
Associate Professor of Pediatric Surgery and Pediatrics
Vanderbilt University
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