A study of efficacy and safety of intravenous Fos aprepitant versus oral Aprepitant in prevention of chemotherapy induced nausea and vomiting in children a randomized controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- To compare the complete response (defined as absence of retching, vomiting /use
研究概览
简要总结
Chemotherapy induced nausea and vomiting (CINV) is one of the most feared side effects of cancer treatment . It affects 70% of pediatric patients
undergoing cancer chemotherapy. Effective management of CINV is critical in children as they are often more vulnerable to both the immediate discomfort of nausea and vomiting and the long-term impacts, including malnutrition, dehydration, and psychological distress.
There is paucity of data related to usage of fosaprepitant and oral aprepitant in pediatric oncology patients. This study aims to determine the
efficacy and safety of intravenous fosparepitant versus oral aprepitant in prevention of CINV in pediatric oncology patients . Following are the advantages of fosaprepitant over aprepitant
-
Single dose administration ensures compliance and ease of administration .There is reduced chances of missed doses if patients are treated on outpatient basis.
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It is beneficial in those children who have difficulty in swallowing capsules or who vomit out capsules in the peri-chemotherapy period .As of now , Aprepitant is available only as as capsules in India .
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With regard to weight-based dosing, fosaprepitant can be more precisely dosed when compared to aprepitant capsules in children .
The patient data will be collected on a predesigned proforma. Chemo-naive patients planned for 1 st cycle of chemotherapy will be enrolled
in the study .They will be randomly assigned to intervention arm A or arm B by computer generated randomization blocks. The randomization blocks
which will be with an individual not involved in study enrolment, administration of intervention, data collection or data analysis. The intervention arm A will receive fosaprepitant plus dexamethasone plus ondansetron and Arm B will receive aprepitant plus dexamethasone plus ondansetron. All the enrolled patients will be followed up for a period of 0- 120 hours from the last administered chemotherapy dose . The caregivers or parents
shall be asked to maintain a diary mentioning the number of events of vomiting and nausea along with time , feeds and fluids taken orally. PeNat visual assessment tool (Kannada translation) will be used to report the number of nausea events in a day (after validation in pilot population).
Absence of vomiting or retching, need for rescue medications during the specified period will be taken as complete response to therapy and presence
of vomiting , retching and need for rescue medications during the specified period will be considered as partial response to therapy. The results will be analyzed by R4.4.1. Analysis will be done on Intention to treat basis. Comparison between categorical variables will be done by chi-square test, proportions are compared with Z test and continuous variables will be compared by Student’s t test. A significance level of 0.05 will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 4.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged between 4 to 15 years diagnosed with malignancy, who are treated with first cycle highly emetogenic chemotherapy (as per Pediatric Oncology Group of Ontario POGO clinical practice guidelines endorsed by Childrens Oncology Group COG supportive care guidelines taskforce) and weighing more than 15 kg .
排除标准
- •1.Preexisting vomiting within 48 hours prior to chemotherapy due to any cause.
- •2.Children allergic to 5HT3 antagonists ,aprepitant and Fosaprepitant.
- •3.Patients with congestive cardiac failure or QT prolongation .
- •4.Deranged renal (creatinine more than upper limit of normal for age ) or hepatic function (transaminases 3 times upper limit of normal and or bilirubin 1.5 times upper limit of normal ).
- •5.Recent radiation therapy to abdomen or pelvis in the previous 1 week .
- •6.Primary or metastatic central nervous system malignancy causing raised intracranial pressure.
- •7.Patients started on systemic corticosteroid therapy 72 hours prior to study drug administration or planned to receive corticosteroid as part of therapy.
- •8.Patients on warfarin, itraconazole, everolimus, clarithromycin, phenytoin, rifampicin, carbamazepine, antiHIV therapy or ketoconazole.
- •9.Patients initiated on opioids within 48 hours of study enrollment and treatment.
- •10.Patients refusing consent or not willing for followup.
结局指标
主要结局
To compare the complete response (defined as absence of retching, vomiting /use
时间窗: acute phase (0-24 hours within | administration of chemotherapy) in both arms of the study
of rescue medications) rate during the acute phase (0-24 hours within
时间窗: acute phase (0-24 hours within | administration of chemotherapy) in both arms of the study
administration of chemotherapy) in both arms of the study( Arm A Fosaprepitant
时间窗: acute phase (0-24 hours within | administration of chemotherapy) in both arms of the study
plus dexamethasone plus ondansetron , Arm B :aprepitant plus dexamethasone
时间窗: acute phase (0-24 hours within | administration of chemotherapy) in both arms of the study
plus ondansetron) .
时间窗: acute phase (0-24 hours within | administration of chemotherapy) in both arms of the study
次要结局
- 1. To determine the patients who achieved complete response in delayed phase(24-120 hours after administration of last dose of chemotherapy in both arms of the)
研究者
SRIDEVI R
Kidwai Memorial Institute Of Oncology