An interventional study of Fosaprepitant and Placebo(normal saline) in Chemotherapy Induced Nausea and Vomiting Pediatric Cancer Patients, sponsored by Shanghai Children's Medical Center. Status unknown at 1 site in China. Open to participants aged 2 Years to 12 Years. Per ClinicalTrials.gov, last updated 2022-02-09.
Sponsored by Shanghai Children's Medical Center · Not applicable, Interventional, and Treatment
This study was a prospective, randomized, double-blind, parallel controlled clinical trial. The children who met the inclusion criteria and were treated with medium and high emetic chemotherapy drugs were randomly included in the experimental group (forsapitan group) and the control group (placebo group) in the ratio of 1 ∶ 1. The children in the experimental group were infused with fosapitan, dexamethasone and granisetron before chemotherapy, and then continued to be infused with granisetron and dexamethasone until 48 hours after the end of chemotherapy. The antiemetic regimen of children in the control group was placebo instead of fosapitan, and the others were the same as those in the experimental group. In this study, CNNC antiemetic scale and pediatric scale proposed by Dupuis were used to evaluate the vomiting data. The primary end point was the proportion of children who achieved complete remission (CR) in the delayed period (within 24-120 hours after the start of chemotherapy); The secondary end points were the CR rate in the acute phase (within 24 hours after the first chemotherapy administration) and the overall phase. The antiemetic efficacy and adverse reactions of the two groups were observed and analyzed.
1,123 studies on the registry are indexed under Vomiting; 137 are open to participants now.
This study's planned enrollment of 120 is above the median of 105 across 954 interventional studies indexed under Vomiting.
Browse Vomiting studies →Shanghai Children's Medical Center is the lead sponsor of 38 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
Patients received intravenous Ganisetron plus dexamethasone followed by fosaprepitant infusion
Drug: Fosaprepitant
Patients received intravenous Ganisetron plus dexamethasone followed by normal saline
Drug: Placebo(normal saline)
Fosaprepitant: 4 mg/kg IV Granisetron+dexamethasone: granisetron:40mcg/kg, IV ; dexamethasone : S\<0.6m2, 2 mg/dose, q12h IV/PO; S\>0.6m2, 4 mg/dose, q12h , IV/PO. When used with fosaprepitant, dexamethasone dose was halved.
Placebo(normal saline): 4 ml/kg IV Granisetron+dexamethasone: granisetron:40mcg/kg, IV ; dexamethasone : S\<0.6m2, 2 mg/dose, q12h IV/PO; S\>0.6m2, 4 mg/dose, q12h , IV/PO.
Complete remission rates in the acute phases
The primary end point was complete remission rates in the acute phase. Complete Remission was defined as no vomiting, no retching, and no use of rescue medecation
Time frame: up to 6 months
Complete Remission rates in the delayed and overall phases
Complete Remission rates in the delayed and overall phases
Time frame: up to 6 months
Adverse events reported in study patients
All of the adverse reaction of aprepitant and fosaprepitant during the study
Time frame: up to 6 months
Plan to share: No
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fosaprepitant
Shanghai Children's Medical Center