comparison of two drugs named olanzapine and metoclopramide for treatment of vomiting in children with cancer getting chemotherapy medicine
- Conditions
- Health Condition 1: C969- Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecifiedHealth Condition 2: C409- Malignant neoplasm of unspecifiedbones and articular cartilage of limb
- Registration Number
- CTRI/2018/08/015210
- Lead Sponsor
- Cancer Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
1. Patients between 5-18 years of age
2. Receiving NK-1 inhibitor (Aprepitant/Fosaprepitant) and 5HT-3 antagonist (ondansetron/palnosetron) and/or dexamethasone as prophylactic anti-emetics for CINV due to moderate to highly emetogenic chemotherapy (Appendix A and B).
3. Parents/guardian providing written consent to participate in the study.
4. Patients who develop breakthrough vomiting after starting prophylactic anti-emetics
5. Patients should have no history of CNS disease including brain metastasis, seizure disorder or psychosis
6. Patient should not be on treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine or phenothiazine.
7. Lansky performance scale of above 50 or ECOG performance scale less than 3.
1. Patient, allergic to olanzapine or metoclopramide
2. Patient has renal failure, congestive heart failure or any uncontrolled disease except for malignancy
3. Patient has diabetes mellitus
4. SGOT/SGPT >4 x upper limit of normal (ULN) and Bilirubin >1.5 x ULN
5. Serum creatinine > ULN
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Compare the response rates between olanzapine and metoclopramide for treating breakthrough chemotherapy induced nausea and vomiting.Timepoint: Three days from initiation of olanzapine or metoclopramide
- Secondary Outcome Measures
Name Time Method Compare the toxicity between olanzapine and metoclopramide when used for treating breakthrough chemotherapy induced nausea and vomiting .Timepoint: Three days from initiation of olanzapine or metoclopramide