Health Condition 1: R111- Vomiting
Conditions
Interventions
Intervention1: Fosaprepitant 3mg/kg
Palnosteron 0.02mg/kg
Dexamethasone 0.15mg/kg: Patient randomized to fosaprepitant arm will receive foraprepitant 3mg/kg (maxium 150mg) as a short IV infusion in 10
Sponsors
Hemato Oncology Clinic
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged between 1 to 12 years Patients with Histologically or cytological confirmed tumors Patient naïve to chemotherapy. Scheduled to receive their first course of chemotherapy (HEC/MEC) for treatment of a solid malignant tumor. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 Predicted life expectancy of at least 3 months Willing to provide written informed consent by parent or guardian and oral assent by patient.
Exclusion criteria
Exclusion criteria: Radiation therapy to the abdomen or pelvis within 1 week before day 1 or between day 1 and 5. Bone marrow or stem-cell transplant. Vomiting, retching, or more than mild nausea within 24 hours before day 1 Children with allergy to NK-1 antagonists or 5HT3 antagonists Children with active infection Children with congestive heart failure or known history of QT prolongation on electrocardiogram Abnormal blood parameter (absolute neutrophil count Abnormal kidney function indicated by a serum creatinine more than the upper limit of normal (ULN) for age Abnormal liver function test indicated by serum aspartate aminotransferase and alanine aminotransferase five times the ULN for age and serum bilirubin 1.5 times the ULN for age Not willing to participate in the study or who have participated in any other clinical study in past 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients who achieved a complete response (defined as no vomiting, no use of rescue medication) during the 25â??120 hours (delayed phase). Timepoint: 1. no vomiting, no use of rescue medication) during the 25â??120 hours (delayed phase) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients who achieved complete response during the acute (0â??24 hours) and overall phases. 2. Any adverse effect seen or reported by patient/caretaker.Timepoint: 1. 0 - 24 hrs 2. 6 days | — |
Countries
India
Contacts
Public ContactDr Deepa Hiren Trivedi
Hemato Oncology Clinic
Outcome results
None listed