Health Condition 1: C00-D49- Neoplasms Health Condition 2: null- Pediatric cancer patients undergoing chemotherapy
Conditions
Interventions
Intervention1: Arm A: Fosaprepitant arm: Patients, randomized to fosaprepitant arm will get fosaprepitant 3 mg/kg (max 150 mg) as short IV infusion in 100 ml normal saline over 30 minutes. Fosaprepita
maximum: 16mg) as an intravenous bolus followed by dexamethasone (0.15 mg/kg) as 15-min intravenous infusion in 100 ml normal saline 45 min prior to chemotherapy.
In addition to intravenous ondansetro
Sponsors
Cancer Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient is 1 to 12 years of age at time of study entry. 2. Weight less than 30 kg. 3. Parent/guardian (legally authorized representative) agrees to the patientâ??s participation as indicated by parent/legal guardian signature on the informed consent form. 4. Patient is scheduled to receive chemotherapeutic agent(s) associated with moderate, high, or very high risk of emetogenicity for a documented malignancy. 5. Patient >10 years of age has a Karnofsky score >=60; patient =60. 6. Patient has a predicted life expectancy of >=3 months.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome :- proportion of patients who achieved a complete response (defined as no vomiting, no retching, and no use of rescue medication) during the 25â??120 h (delayed phase) after initiation of emetogenic chemotherapy Timepoint: 24 hours from administration of drug to 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome:- proportion of patients who achieved complete response during the acute (0â??24 h) and overall phases. (0â??120 h), and no vomiting (regardless of rescue medication use) during the acute, delayed, and overall phases Timepoint: from administration of drug to 7 days | — |
Countries
India
Contacts
Public ContactVenkatraman Radhakrishnan
Cancer Institute
Outcome results
None listed