Olanzapine as a medication to reduce nausea and vomiting following chemotherapy in children

Evaluation of the efficacy and safety of adding olanzapine to the standard preventive regimen for chemotherapy- induced nausea and vomiting in children of 4-18 years of age, a Randomized Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090613002027N14

Enrollment

Registered

2018-11-11

Start date

2018-01-01

Completion date

Unknown

Last updated

2019-01-14

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

Conditions

Palliative care. Encounter for palliative care

Interventions

Intervention 1: First intervention group (Control): consist of children age of 4-18 years old undergoing chemotherapy with moderate to high risk emetogenicity will receive usual prophylactic antiemeti

Eligibility

Sex/Gender

All

Age

4 Years to 18 Years

Inclusion criteria

Inclusion criteria: Cognitive abilities of 4 years old age Receiving chemotherapy medications with moderate to severe risk of emesis Age between 4 to 18 years old

Exclusion criteria

Exclusion criteria: Brain tumor Receive of any anti psychotics 30 days before enrollment Inhibitors/Inducers of CYP1A2 History of neuroleptic malignant syndrome History of seizure Sensitivity to olanzapine Cardiac arrhythmia History of uncontrolled diabetes mellitus

Design outcomes

Primary

Measure	Time frame
Frequency of nausea in the first 5 days after chemotherapy. Timepoint: Baseline, 1, 2, 3, 4 and 5 days after intervention. Method of measurement: Interview with the patient.;Frequency of vomiting in the first 5 days after chemotherapy. Timepoint: Baseline, 1, 2, 3, 4 and 5 days after intervention. Method of measurement: Interview with the patient.	—

Secondary

Measure	Time frame
Severity of Nausea during 5 days following chemotherapy. Timepoint: Baseline and days 1, 2, 3, 4 and 5 after intervention. Method of measurement: National Cancer Institute Common Terminology Criteria for Adverse Events version 4.;Severity of Vomiting during 5 days following chemotherapy. Timepoint: Baseline and days 1, 2, 3, 4 and 5 after intervention. Method of measurement: National Cancer Institute Common Terminology Criteria for Adverse Events version 4.;Fasting plasma glucose. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit.;Fasting triglyceride. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit.;Total Choleterol. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit.;???Aspartate aminotransferase. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit.;Alanine aminotransferase. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit.;Prolactine. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit.	—

Measure

Time frame

Severity of Nausea during 5 days following chemotherapy. Timepoint: Baseline and days 1, 2, 3, 4 and 5 after intervention. Method of measurement: National Cancer Institute Common Terminology Criteria for Adverse Events version 4.;Severity of Vomiting during 5 days following chemotherapy. Timepoint: Baseline and days 1, 2, 3, 4 and 5 after intervention. Method of measurement: National Cancer Institute Common Terminology Criteria for Adverse Events version 4.;Fasting plasma glucose. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit.;Fasting triglyceride. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit.;Total Choleterol. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit.;???Aspartate aminotransferase. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit.;Alanine aminotransferase. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit.;Prolactine. Timepoint: Baseline and 5 days after intervention. Method of measurement: Laboratory Kit.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactEbrahim Salehifar

Sari University of Medical Sciences

esalehifar@mazums.ac.ir+98 15 1311 6546

Outcome results

None listed

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