Health Condition 1: null- Pediatric cancer patients on chemotherapy
Conditions
Interventions
Intervention1: Palonosetron: We will use palonosetron (5 mcg/kg/dose (max. 250 mcg) single dose for 72 hours) and dexamethasone (5 mg/m2/dose, max. 8 mg, 12 hourly for duration of chemotherapy) for C
Sponsors
Christian Medical College Fluid Grant
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children and adolescents with malignancy receiving moderately or highly emetogenic chemotherapy 2. Expected to receive at least 1-2 chemotherapy cycles (effect on 2nd cycle will be studied if 2 or more cycles were given. 3. Corticosteroid containing chemotherapy regimens will be included but dexamethasone will not be given additionally for antiemetic purpose.
Exclusion criteria
Exclusion criteria: 1. Age 2. Intracranial malignancies/disorders/use of anticonvulsants 3. Abdominal or cranial irradiation 4. Nausea/vomiting/antiemetic use within 24 hours before 5. chemotherapy 5. Hepatic/renal/cardiovascular impairment 6. Electrolyte imbalance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Zero CINV (chemotherapy induced nausea and vomiting) for early (within 24 hour), Delayed vomiting (24-120 hours) and overall (0-120 hours) period after completion of chemotherapy.Timepoint: 24 hrs and 120 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse eventTimepoint: 24 hrs and 120 hours;CTCAE Grading of nausea and vomiting- Grading of Nausea (only more than 3 years age) â?¢ Loss of appetite- grade 1 â?¢ Oral intake decreased-grade 2 â?¢ Inadequate oral caloric or fluid intake- grade 3 Grading of vomiting: no of episodes in 24 hours (1 episode is defined as any vomiting separated by no more than 5 min interval.) â?¢ 1 episode -grade 1, â?¢ 2 â?? 5 episodes-grade 2, â?¢ â?¥6 episodes -grade 3, â?¢ Life-threatening -grade 4, â?¢ Death-grade 5.Timepoint: 24 hrs and 120 hours;Effect on anticipatory nausea or vomiting (nausea or vomiting on day 1 of chemotherapy before starting chemotherapy) in next cycle of chemotherapyTimepoint: 24 hrs and 120 hours;Overall satisfaction with the nausea-vomiting experience on a four-point Likert scale (dissatisfied, neutral, satisfied, and highly satisfied) at the time of discharge from ward/day care.Timepoint: 24 hrs and 120 hours;Use of rescue medications (for grade 2 or more nausea/vomiting)Timepoint: 24 hrs and 120 hours | — |
Countries
India
Contacts
Public ContactNARENDRA KUMAR CHAUDHARY
Christian Medical College, Vellore
Outcome results
None listed