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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fosaprepitant | Experimental | Patients received intravenous Ganisetron plus dexamethasone followed by fosaprepitant infusion |
|
| Placebo | Placebo Comparator | Patients received intravenous Ganisetron plus dexamethasone followed by normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fosaprepitant | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission rates in the delayed and overall phases | Complete Remission rates in the delayed and overall phases | up to 6 months |
| Adverse events reported in study patients | All of the adverse reaction of aprepitant and fosaprepitant during the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liting Yu | Contact | 13636303912 | yuliting20091396@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yijin Gao | Shanghai Children's Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Children's Medical Center | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26960036 | Background | Flank J, Robinson PD, Holdsworth M, Phillips R, Portwine C, Gibson P, Maan C, Stefin N, Sung L, Dupuis LL. Guideline for the Treatment of Breakthrough and the Prevention of Refractory Chemotherapy-Induced Nausea and Vomiting in Children With Cancer. Pediatr Blood Cancer. 2016 Jul;63(7):1144-51. doi: 10.1002/pbc.25955. Epub 2016 Mar 9. | |
| 26449391 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 3, 2022 | |
| Reset | Jul 3, 2023 |
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| Placebo(normal saline) | Drug | 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. |
|
| up to 6 months |
| Weinstein C, Jordan K, Green SA, Camacho E, Khanani S, Beckford-Brathwaite E, Vallejos W, Liang LW, Noga SJ, Rapoport BL. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: results of a randomized, double-blind phase III trial. Ann Oncol. 2016 Jan;27(1):172-8. doi: 10.1093/annonc/mdv482. Epub 2015 Oct 8. |
| 30426714 | Background | Radhakrishnan V, Joshi A, Ramamoorthy J, Rajaraman S, Ganesan P, Ganesan TS, Dhanushkodi M, Sagar TG. Intravenous fosaprepitant for the prevention of chemotherapy-induced vomiting in children: A double-blind, placebo-controlled, phase III randomized trial. Pediatr Blood Cancer. 2019 Mar;66(3):e27551. doi: 10.1002/pbc.27551. Epub 2018 Nov 13. |
| 30900392 | Background | Mora J, Valero M, DiCristina C, Jin M, Chain A, Bickham K. Pharmacokinetics/pharmacodynamics, safety, and tolerability of fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting in pediatric cancer patients. Pediatr Blood Cancer. 2019 Jun;66(6):e27690. doi: 10.1002/pbc.27690. Epub 2019 Mar 21. |
| 23512831 | Background | Dupuis LL, Boodhan S, Holdsworth M, Robinson PD, Hain R, Portwine C, O'Shaughnessy E, Sung L; Pediatric Oncology Group of Ontario. Guideline for the prevention of acute nausea and vomiting due to antineoplastic medication in pediatric cancer patients. Pediatr Blood Cancer. 2013 Jul;60(7):1073-82. doi: 10.1002/pbc.24508. Epub 2013 Mar 19. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 3, 2022 | Jul 3, 2023 |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C579707 | fosaprepitant |
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