Health Condition 1: R110- Nausea Health Condition 2: R111- Vomiting
Conditions
Interventions
Intervention1: injection fosaprepitant: Injection fosaprepitant is an intravenous preparation of NK receptor antagonist approved for use in prevention of nausea and vomiting in children and adults rec
41 to 65 kg on day 1 125 mg
and days 2 and 3 80 mg)In this study patients enrolled in Arm B will receive oral aprepitant plus dexamethasone plus ondansetron
Sponsors
SRIDEVI R
Eligibility
Inclusion criteria
Inclusion criteria: 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 .
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the complete response (defined as absence of retching, vomiting /use of rescue medications) rate during the acute phase (0-24 hours within administration of chemotherapy) in both arms of the study( Arm A Fosaprepitant plus dexamethasone plus ondansetron , Arm B :aprepitant plus dexamethasone plus ondansetron) . Timepoint: acute phase (0-24 hours within administration of chemotherapy) in both arms of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 study 2.To determine the patients who achieved overall complete response during the chemotherapy cycle.in both arms of the study 3.Percentage of patients requiring rescue anti-emetics. chemotherapy in both arms of the study 4.To determine the adverse effects associated with aprepitant and fosaprepitant usage.Timepoint: delayed phase 24-120 hours after administration of last dose of chemotherapy in both arms of the study | — |
Countries
India
Contacts
Public ContactSRIDEVI R
Kidwai Memorial Institute Of Oncology
Outcome results
None listed