Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-07-30

Brief Summary

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Breakthrough chemotherapy-induced vomiting (CIV) is defined as CIV occurring after adequate antiemetic prophylaxis. Olanzapine is recommended for the treatment of breakthrough CIV in children, without adequate evidence. We conducted an open-label, single-center, phase 3 randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CIV.

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Detailed Description

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Children aged 5-18 years who developed breakthrough CIV after receiving highly emetogenic chemotherapy were randomly assigned to the control(placebo) or olanzapine arm. The primary objective of the study was to compare the complete response (CR) rates between patients receiving olanzapine or placebo for treating breakthrough CIV during 72 hours after the administration of the study drug. Secondary objectives were to compare CR rates for nausea and toxicities between the two arms.

Conditions

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Breakthrough Chemotherapy-Induced Vomiting (CIV) in Pediatric Patients Pediatric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The control group gave patients oral placebo, while the experimental group gave patients oral olanzapine

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Patients were randomized to one of the prespecified two arms (arm A: olanzapine or arm B: placebo) if they developed breakthrough vomiting. The department of biostatistics and cancer registry at the institute assisted in the random allocation of the patients. Randomization was performed by generating random number tables through customized computer program or the proposed total number of cases in the study, and the randomization codes were kept in sequentially numbered sealed envelopes. The envelopes were kept in the pediatric ward and opened when a patient was identified for randomization. A document was then prepared giving the allocation of all the subjects to the two arms in chronological order.

Study Groups

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Olanzapine group

Oral olanzapine tablets

Group Type EXPERIMENTAL

Olanzapine Tablets

Intervention Type DRUG

Oral olanzapine tablets

Control group

Oral placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral placebo

Interventions

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Olanzapine Tablets

Oral olanzapine tablets

Intervention Type DRUG

Placebo

Oral placebo

Intervention Type DRUG

Eligibility Criteria

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Exclusion Criteria

* Children with history of allergy to olanzapine or metoclopramide; patient with renal failure, congestive heart failure, or any uncontrolled disease except for malignancy; serum creatinine more than upper limit of normal (ULN) for age; serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) four times the ULN for age and serum bilirubin 1.5 times ULN for age; patient with history of central nervous system disease including brain metastasis, seizure disorder, or psychosis; patients on treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, or phenothiazine.

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No