Chemotherapy-induced Nausea and Vomiting in Children Receiving Intrathecal Methotrexate With/Without Vincristine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Acute Chemotherapy-Induced Nausea and Vomiting
研究概览
简要总结
Chemotherapy induced nausea is a common side effect for children undergoing chemotherapy. Furthermore, chemotherapy-induced vomiting is a major factor limiting quality of life during treatment reported by paediatric cancer survivors. Complete prevention of both nausea and vomiting is the goal of anti-vomiting and nausea medications. It is important to understand whether or not certain chemotherapeutic treatments are more or less likely to cause these symptoms. Acute leukemia is the most common cancer diagnosed in children. Intrathecal methotrexate is an important part of chemotherapy for the prevention and treatment of central nervous system leukemia over the 2.5 to 3.5 years of the treatment program for leukemia. The likelihood that intrathecal methotrexate administered as monotherapy will cause nausea and vomiting has not yet been described in children. Knowledge of the likelihood that intrathecal methotrexate will cause nausea and vomiting will therefore be important to optimize treatment for these side-effects of chemotherapy. The primary aim of this prospective study is to evaluate the potential of intrathecal methotrexate to cause nausea and vomiting in paediatric cancer patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •4 years old to 18 years of age (age range in which the PeNAT has been validated) [18]
- •English speaking (PeNAT has been validated only in English)
- •Cognitive ability of the child believed to be at least at a 4 year old level according to parent or health care professional
- •Patients are past their first cycle of maintenance therapy to avoid interactions with the intensive chemotherapy phase.
排除标准
- •Receiving chemotherapy other than dictated by protocol for maintenance therapy within 24 hours prior to or 24 hours following receipt of intrathecal methotrexate
结局指标
主要结局
Acute Chemotherapy-Induced Nausea and Vomiting
时间窗: Over 24 hours after receiving intrathecal methotrexate on day 1
To describe the prevalence of acute phase CINV in these patients. Acute CINV is defined as nausea, vomiting or retching occurring within the first 24 hours following chemotherapy.
次要结局
- Delayed Chemotherapy-Induced Nausea and Vomiting(Over 168 hours (7 days) after receiving first treatment of intrathecal methotrexate)
- Anticipatory Chemotherapy-Induced Nausea and Vomiting(Baseline)
研究者
Angela Punnett
Staff Physician
The Hospital for Sick Children