Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: fosaprepitant: The study will be conducted at paediatrics hemat-oncology ward of Dr. RML Hospital New Delhi. children (aged 0.5 to 18yrs) suffering from any malignancy who are due for a
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 0.5 to 18 years suffering from any malignancy who are scheduled to receive moderately emetogenic chemotherapy in the pediatric oncology department of Dr. RML Hospital, Delhi.
Exclusion criteria
Exclusion criteria: Patients were excluded from the study if they had any of the following conditions at the time of initial presentation: 1)Vomiting or retching within 24 hours before the start of therapy or having any other risk factors factor responsible for vomiting other than chemotherapy, such as radiation therapy, gastric motility issues, bowel obstruction, brain or spinal metastases 2)Critically ill patients. 3)Known hypersensitivity to fosaprepitant. 4)Patients taking medications that interact with fosaprepitant, such as warfarin, everolimus, tolbutamide, clarithromycin, nefazodone, paroxetine, itraconazole, ketoconazole, anti-HIV medications, carbamazepine, phenytoin, and rifampin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of children with CR(complete response) defined as no episode of vomiting for 120 hours post chemotherapy in both the groups.Timepoint: Percentage of children with CR(complete response) defined as no episode of vomiting for 120 hours post chemotherapy in both the groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)The severity of CINV with fosaprepitant vs dexamethasone groups for 5 days in terms of a)number of episodes of vomiting b)need for use of rescue medications c)time of onset of first episode of vomiting. 2)The incidence of fatigue, headache, constipation, abdominal pain, cough, anorexia diarrhoea hypersensitivity reaction, febrile neutropenia & hypertension in both the groups All the observations will be made for first five daysTimepoint: 5 days from onset of chemotherapy | — |
Countries
India
Contacts
Public ContactDr Muskaan Jain
Dr RML Hospital and ABVIMS
Outcome results
None listed