Health Condition 1: C00-D49- Neoplasms
Conditions
Interventions
Intervention1: Arm B (OPF regimen): Experimental arm: Day 1:
1. Fosaprepitant
� 12-18 years: 150 mg IV over 30 minutes.
� 2 years to less than 12 years: 4 mg/kg (maximum dose 150 mg) intr
Sponsors
Cancer Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 1 to 18 years and diagnosed with cancer. 2. Receiving single-day HEC. 3. Chemotherapy Na�¯ve. 4. Absence of vomiting 24 hours before enrollment. 5. Eastern Cooperative Oncology Group performance status of 0, 1 or 2. 6. Adequate organ function as confirmed by laboratory investigations within two weeks [Aspartate transaminase (AST) and Alanine transaminase (ALT) within 3 times upper limit of normal (ULN), serum bilirubin less than 2 mg/dL, serum creatinine within ULN]. 7. Written informed consent from parents before enrollment. Children above 7-13 years of age will need to provide verbal assent. Children between 14-18 years of age will need to provide written assent.
Exclusion criteria
Exclusion criteria: 1. Patients receiving steroids as part of the chemotherapy regimen or steroids are needed as pre-medication to prevent allergic reactions. 2. Patients receiving multi-day chemotherapy in a chemotherapy block. 3. Patients with brain metastasis. 4. Patients receiving concurrent radiotherapy with chemotherapy. 5. Patients in whom there are contraindications for corticosteroid use like uncontrolled diabetes mellitus, uncontrolled hypertension and active peptic ulcer disease. 6. History of allergy to any of the drugs used for anti-emetic prophylaxis. 7. Treatment with another antipsychotic agent such as risperidone, quetiapine, clozapine, phenothiazine, or butyrophenone for 30 days before or during the protocol therapy. 8. Known cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous six months. 9. History of neurological disorder including seizures and stroke within last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of patients with no episodes of vomiting and no use of rescue medication (CR) during the overall phase (0 to 120 hours).Timepoint: Primary outcome will be assessed till day 5 (120 hours). | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of toxicities between the two regimens.Timepoint: Till the initiation of next chemotherapy cycle.;The number of patients above 5-years with CR to nausea for the overall, acute, and delayed phasesTimepoint: 0-120 hours from chemotherapy administration;The number of patients with CR to vomiting during the acute phase (0 to 24 hours).Timepoint: End of 24 hours from administration of chemotherapy.;The number of patients with CR to vomiting during the delayed phase (24 to 120 hours).Timepoint: 24 hours to 120 hours from chemotherapy administration | — |
Countries
India
Contacts
Public ContactVenkatraman Radhakrishnan
Cancer Institute
Outcome results
None listed