Comparison of effectiveness of two drugs (palonosetron and ondansetron) in prevention of vomiting in children receiving chemotherapy.
Phase 3
- Conditions
- Health Condition 1: null- Pediatric cancer patients on chemotherapy
- Registration Number
- CTRI/2014/03/004492
- Lead Sponsor
- Christian Medical College Fluid Grant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
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
1. Age <4 yrs
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method