comparison of two drugs named olanzapine and metoclopramide for treatment of vomiting in children with cancer getting chemotherapy medicine

Olanzapine versus metoclopramide for the treatment of breakthrough chemotherapy-induced nausea and vomiting in children: a randomised phase 3 trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/08/015210

Enrollment

Registered

2018-08-06

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C969- Malignant neoplasm of lymphoid, hematopoietic and related tissue, unspecified Health Condition 2: C409- Malignant neoplasm of unspecifiedbones and articular cartilage of limb

Interventions

Intervention1: Olanzapine: Olanzapine will be given orally as tablet form. The weight-based schedule of olanzapine is given below 1. 10 kg-20 kg: 2.5 mg OD 2. 20 kg and above: 5 mg OD Olanzapine will

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

India

Contacts

Public ContactVenkatraman Radhakrishnan

Cancer Institute

venkymd@gmail.com9498082771

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026