A Pilot Study of Granulocyte Colony-Stimulating Factor Starting at 24 Hours vs 72 Hours in Pediatric Oncology Patients
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of hospital admissions for febrile neutropenia
研究概览
简要总结
Chemotherapy places patients at an increased risk of infection. A medication called granulocyte colony-stimulating factor is given as a daily injection in order to help decrease the risk of infection. The purpose of this study is to determine the best time to begin granulocyte colony-stimulating factor while maintaining the same clinical benefits. The current study aims to fill these research gaps and address the general question: Can G-CSF safely be given 72 hours following the last day of chemotherapy without increasing the incidence of febrile neutropenia, the duration of neutropenia, or causing increased delays in the next course of chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric oncology patients will be eligible to participate in this study if they meet the following inclusion criteria:
- •are between the ages of birth and 21 years old
- •is diagnosed with an oncologic disease
- •is being treated at UMMC Children's Cancer Clinic
- •will receive G-CSF as part of their standard or experimental oncology treatment protocol between January 1, 2019 and December 31,
- •Oncology treatment protocols are typically derived from the Children's Oncology Group standard of care or patients can be enrolled on a Children's Oncology Group treatment study.
- •is within first four courses of chemotherapy treatment
排除标准
- •Patients will be excluded from the current study if:
- •G-CSF was added to their oncology treatment protocol due to previous complications but for whom G-CSF was not part of their original treatment protocol.
- •are being treated for relapsed disease
- •has clinical evidence of bone marrow involvement
研究组 & 干预措施
Receive G-CSF 72 hours following chemotherapy
Children will be enrolled during the first four rounds of chemotherapy. Upon enrollment, children will receive G-CSF at 24 hours following chemotherapy. G-CSF will be discontinued when absolute neutrophil count (ANC) has increased post nadir in accord with G-CSF administration guidelines. Parents and children will then complete questionnaires to determine rates of side effects and needle distress at the end of G-CSF during their next regular outpatient oncology clinic visit.
Following children's next course of chemotherapy, G-CSF will be started 72 hours after completion of chemotherapy.
干预措施: Granulocyte Colony-Stimulating Factor (Drug)
结局指标
主要结局
Incidence of hospital admissions for febrile neutropenia
时间窗: From date of completion of course of chemotherapy until date of the initiation of next chemotherapy course, assessed up to 1 year
Febrile neutropenia is defined as a temperature greater than or equal to 38 degrees Celsius and ANC less than or equal to 500
次要结局
- Days delayed in beginning the next course of chemotherapy(Will be assessed weekly until the next course of chemotherapy is initiated, up to 1 year)
- Duration of neutropenia(From date of first recorded ANC following chemotherapy until date of first ANC that is greater than 500 following nadir, assessed up to 1 year)